<description value="Representation of a device record instance in the UDI system" /> <status value="draft" /> <fhirVersion value="5.0.0" /> <kind value="resource" /> <abstract value="false" /> <type value="DeviceDefinition" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" /> <derivation value="constraint" /> <differential> <element id="DeviceDefinition"> <path value="DeviceDefinition" /> <short value="Representation of a device registration instance in the UDI system" /> </element> <element id="DeviceDefinition.extension"> <path value="DeviceDefinition.extension" /> <min value="1" /> </element> <element id="DeviceDefinition.extension:refurbisherReprocessingCompany"> <path value="DeviceDefinition.extension" /> <sliceName value="refurbisherReprocessingCompany" /> <short value="Refurbisher/Reprocessing Company's information" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/RefurbisherReprocessingCompany" /> </type> </element> <element id="DeviceDefinition.extension:legalManufacturer"> <path value="DeviceDefinition.extension" /> <sliceName value="legalManufacturer" /> <short value="Legal Manufacturer's information" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/LegalManufacturer" /> </type> </element> <element id="DeviceDefinition.description"> <path value="DeviceDefinition.description" /> <max value="0" /> </element> <element id="DeviceDefinition.identifier"> <path value="DeviceDefinition.identifier" /> <max value="0" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier"> <path value="DeviceDefinition.udiDeviceIdentifier" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> <max value="2" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier"> <path value="DeviceDefinition.udiDeviceIdentifier" /> <sliceName value="udiDeviceIdentifier" /> <short value="UDI-DI of the device" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension"> <path value="DeviceDefinition.udiDeviceIdentifier.extension" /> <max value="1" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension:repurposingType"> <path value="DeviceDefinition.udiDeviceIdentifier.extension" /> <sliceName value="repurposingType" /> <short value="Identification of the type of repurposing applied to this UDI-DI's device" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/RepurposingType" /> </type> <isModifier value="false" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.deviceIdentifier"> <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" /> <short value="The UDI-DI number associated with the device" /> <maxLength value="25" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.issuer"> <path value="DeviceDefinition.udiDeviceIdentifier.issuer" /> <short value="The UDI-DI's issuer" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" /> </binding> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.jurisdiction"> <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" /> <short value="The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the "issuer" field" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution"> <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" /> <max value="1" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.start"> <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start" /> <short value="Specify the date from which the company wishes the data to be made public. If left blank, the system will consider the submission date to publish the submitted information" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.end"> <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end" /> <short value="Specify the date when the product will be discontinued, no longer offered on the market" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.subJurisdiction"> <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction" /> <short value="National jurisdiction. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the "issuer" field" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal"> <path value="DeviceDefinition.udiDeviceIdentifier" /> <sliceName value="udiDeviceIdentifierOriginal" /> <short value="UDI-DI of the original device who is being refurbished/reprocessed" /> <max value="1" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.deviceIdentifier"> <path value="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier" /> <short value="The UDI-DI number associated with the device" /> <maxLength value="25" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.issuer"> <path value="DeviceDefinition.udiDeviceIdentifier.issuer" /> <short value="The UDI-DI's issuer" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" /> </binding> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.jurisdiction"> <path value="DeviceDefinition.udiDeviceIdentifier.jurisdiction" /> <short value="The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the "issuer" field" /> </element> <element id="DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution"> <path value="DeviceDefinition.udiDeviceIdentifier.marketDistribution" /> <max value="0" /> </element> <element id="DeviceDefinition.regulatoryIdentifier"> <path value="DeviceDefinition.regulatoryIdentifier" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> <max value="2" /> </element> <element id="DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber"> <path value="DeviceDefinition.regulatoryIdentifier" /> <sliceName value="premarketAuthorizationNumber" /> <short value="The Premarket Authorization Number seen in the Anvisa's product registration" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.type"> <path value="DeviceDefinition.regulatoryIdentifier.type" /> <short value="license | unit-of-use" /> <fixedCode value="license" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" /> </binding> </element> <element id="DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.deviceIdentifier"> <path value="DeviceDefinition.regulatoryIdentifier.deviceIdentifier" /> <maxLength value="11" /> </element> <element id="DeviceDefinition.regulatoryIdentifier:unitOfUseNumber"> <path value="DeviceDefinition.regulatoryIdentifier" /> <sliceName value="unitOfUseNumber" /> <short value="The Unit of Use (UOU) DI Number - Identifier assigned to the individual medical device where UDI is not labeled at the unit of use level" /> <max value="1" /> </element> <element id="DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.type"> <path value="DeviceDefinition.regulatoryIdentifier.type" /> <short value="license | unit-of-use" /> <fixedCode value="unit-of-use" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" /> </binding> </element> <element id="DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.deviceIdentifier"> <path value="DeviceDefinition.regulatoryIdentifier.deviceIdentifier" /> <patternString value="[0-9]+" /> <maxLength value="23" /> </element> <element id="DeviceDefinition.partNumber"> <path value="DeviceDefinition.partNumber" /> <short value="Catalog Number" /> <maxLength value="80" /> </element> <element id="DeviceDefinition.manufacturer"> <path value="DeviceDefinition.manufacturer" /> <max value="0" /> </element> <element id="DeviceDefinition.deviceName"> <path value="DeviceDefinition.deviceName" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="2" /> <max value="2" /> </element> <element id="DeviceDefinition.deviceName:brandName"> <path value="DeviceDefinition.deviceName" /> <sliceName value="brandName" /> <short value="The Brand Name of the device (as indicated by the manufacturer)" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.deviceName:brandName.name"> <path value="DeviceDefinition.deviceName.name" /> <maxLength value="80" /> </element> <element id="DeviceDefinition.deviceName:brandName.type"> <path value="DeviceDefinition.deviceName.type" /> <fixedCode value="user-friendly-name" /> </element> <element id="DeviceDefinition.deviceName:tradeName"> <path value="DeviceDefinition.deviceName" /> <sliceName value="tradeName" /> <short value="The Trade Name of the product (as seen in the Anvisa's regularization). This field is for query only" /> <max value="1" /> </element> <element id="DeviceDefinition.deviceName:tradeName.name"> <path value="DeviceDefinition.deviceName.name" /> <maxLength value="230" /> </element> <element id="DeviceDefinition.deviceName:tradeName.type"> <path value="DeviceDefinition.deviceName.type" /> <fixedCode value="registered-name" /> </element> <element id="DeviceDefinition.modelNumber"> <path value="DeviceDefinition.modelNumber" /> <short value="Version or model" /> <min value="1" /> <maxLength value="80" /> </element> <element id="DeviceDefinition.classification"> <path value="DeviceDefinition.classification" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> <max value="3" /> </element> <element id="DeviceDefinition.classification:gmdnTerm"> <path value="DeviceDefinition.classification" /> <sliceName value="gmdnTerm" /> <short value="The GMDN nomenclature that characterizes the device" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.classification:gmdnTerm.type"> <path value="DeviceDefinition.classification.type" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/GMDNTerm" /> </binding> </element> <element id="DeviceDefinition.classification:gmdnTerm.justification"> <path value="DeviceDefinition.classification.justification" /> <max value="0" /> </element> <element id="DeviceDefinition.classification:riskClassification"> <path value="DeviceDefinition.classification" /> <sliceName value="riskClassification" /> <short value="The risk classification of the product (as seen in the Anvisa's regularization). This field is for query only" /> <max value="1" /> </element> <element id="DeviceDefinition.classification:riskClassification.type"> <path value="DeviceDefinition.classification.type" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/RiskClassification" /> </binding> </element> <element id="DeviceDefinition.classification:riskClassification.justification"> <path value="DeviceDefinition.classification.justification" /> <max value="0" /> </element> <element id="DeviceDefinition.classification:anvisaNomenclature"> <path value="DeviceDefinition.classification" /> <sliceName value="anvisaNomenclature" /> <short value="The Anvisa's nomenclature name (as seen in the Anvisa's regularization). This field is for query only" /> <max value="1" /> </element> <element id="DeviceDefinition.classification:anvisaNomenclature.type"> <path value="DeviceDefinition.classification.type" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/CodeSystem/AnvisaNomenclature" /> </binding> </element> <element id="DeviceDefinition.classification:anvisaNomenclature.justification"> <path value="DeviceDefinition.classification.justification" /> <max value="0" /> </element> <element id="DeviceDefinition.conformsTo"> <path value="DeviceDefinition.conformsTo" /> <max value="0" /> </element> <element id="DeviceDefinition.hasPart"> <path value="DeviceDefinition.hasPart" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging"> <path value="DeviceDefinition.packaging" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging"> <path value="DeviceDefinition.packaging" /> <sliceName value="primaryPackaging" /> <short value="Primary Packaging. Specifies the Quantity per Primary Packaging" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging.identifier"> <path value="DeviceDefinition.packaging.identifier" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging.type"> <path value="DeviceDefinition.packaging.type" /> <short value="The identification of the primary packaging" /> <min value="1" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/PackagingLevel" /> <version value="1.0.0" /> <code value="1" /> <display value="Primary packaging" /> </coding> </fixedCodeableConcept> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/PrimaryPackagingLevel" /> </binding> </element> <element id="DeviceDefinition.packaging:primaryPackaging.count"> <path value="DeviceDefinition.packaging.count" /> <short value="Quantity per Primary Packaging" /> <min value="1" /> <minValueInteger value="1" /> <maxValueInteger value="999999999" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging.distributor"> <path value="DeviceDefinition.packaging.distributor" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging.udiDeviceIdentifier"> <path value="DeviceDefinition.packaging.udiDeviceIdentifier" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:primaryPackaging.packaging"> <path value="DeviceDefinition.packaging.packaging" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging"> <path value="DeviceDefinition.packaging" /> <sliceName value="higherLevelsPackaging" /> <short value="Identification of packaging beyond the primary packaging" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.identifier"> <path value="DeviceDefinition.packaging.identifier" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.type"> <path value="DeviceDefinition.packaging.type" /> <short value="The Package Level" /> <min value="1" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/HigherLevelsPackaging" /> </binding> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.count"> <path value="DeviceDefinition.packaging.count" /> <short value="The quantity per packaging" /> <min value="1" /> <minValueInteger value="1" /> <maxValueInteger value="999999999" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.distributor"> <path value="DeviceDefinition.packaging.distributor" /> <max value="0" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.udiDeviceIdentifier"> <path value="DeviceDefinition.packaging.udiDeviceIdentifier" /> <short value="The Package UDI-DI" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.packaging:higherLevelsPackaging.packaging"> <path value="DeviceDefinition.packaging.packaging" /> <max value="0" /> </element> <element id="DeviceDefinition.version"> <path value="DeviceDefinition.version" /> <max value="0" /> </element> <element id="DeviceDefinition.safety"> <path value="DeviceDefinition.safety" /> <short value="The MRI safety status. Specify the level of product safety in an operating magnetic resonance environment" /> <min value="1" /> <max value="1" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/MRSafetyStatus" /> </binding> </element> <element id="DeviceDefinition.shelfLifeStorage"> <path value="DeviceDefinition.shelfLifeStorage" /> <max value="1" /> </element> <element id="DeviceDefinition.shelfLifeStorage.extension"> <path value="DeviceDefinition.shelfLifeStorage.extension" /> <max value="1" /> </element> <element id="DeviceDefinition.shelfLifeStorage.extension:specialPrecautionsForStorageDescription"> <path value="DeviceDefinition.shelfLifeStorage.extension" /> <sliceName value="specialPrecautionsForStorageDescription" /> <short value="Specify storage and/or handling conditions that may directly impact the product's safety and efficacy" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/SpecialPrecautionsForStorageDescription" /> </type> <isModifier value="false" /> </element> <element id="DeviceDefinition.shelfLifeStorage.type"> <path value="DeviceDefinition.shelfLifeStorage.type" /> <max value="0" /> </element> <element id="DeviceDefinition.shelfLifeStorage.period[x]"> <path value="DeviceDefinition.shelfLifeStorage.period[x]" /> <max value="0" /> </element> <element id="DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage"> <path value="DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage" /> <max value="0" /> </element> <element id="DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text"> <path value="DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text" /> <min value="1" /> </element> <element id="DeviceDefinition.languageCode"> <path value="DeviceDefinition.languageCode" /> <max value="0" /> </element> <element id="DeviceDefinition.property"> <path value="DeviceDefinition.property" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="DeviceDefinition.property:deviceCategory"> <path value="DeviceDefinition.property" /> <sliceName value="deviceCategory" /> <short value="Specify if the product corresponds to material, implantable material, equipment, implantable equipment, IVD, or SaMD" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:deviceCategory.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="device-category" /> <display value="Medical Device Category" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:deviceCategory.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/DeviceCategory" /> </binding> </element> <element id="DeviceDefinition.property:singleUse"> <path value="DeviceDefinition.property" /> <sliceName value="singleUse" /> <short value="Indicates if the device labeled as single-use" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:singleUse.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="single-use" /> <display value="Device labeled as single-use" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:singleUse.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:reusableDevice"> <path value="DeviceDefinition.property" /> <sliceName value="reusableDevice" /> <short value="Indicates if the device is reusable" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:reusableDevice.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="reusable-device" /> <display value="Reusable device" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:reusableDevice.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:recommendedReprocessingCyles"> <path value="DeviceDefinition.property" /> <sliceName value="recommendedReprocessingCyles" /> <short value="Specify the number of recommended reprocessing cycles" /> <max value="1" /> </element> <element id="DeviceDefinition.property:recommendedReprocessingCyles.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="recommended-reprocessing-cyles" /> <display value="Number of reprocessing cycles recommended" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:recommendedReprocessingCyles.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="Quantity" /> </type> <minValueQuantity> <value value="1" /> </minValueQuantity> <maxValueQuantity> <value value="999999" /> </maxValueQuantity> </element> <element id="DeviceDefinition.property:labeledAsSterile"> <path value="DeviceDefinition.property" /> <sliceName value="labeledAsSterile" /> <short value="Indicates if the device is labeled as sterile" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:labeledAsSterile.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="labeled-as-sterile" /> <display value="Device labeled as sterile" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:labeledAsSterile.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:requiresSterilization"> <path value="DeviceDefinition.property" /> <sliceName value="requiresSterilization" /> <short value="Indicates if the device requires sterilization before use" /> <max value="1" /> </element> <element id="DeviceDefinition.property:requiresSterilization.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="requires-sterilization" /> <display value="Requires sterilization before use" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:requiresSterilization.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:sterilizationMethod"> <path value="DeviceDefinition.property" /> <sliceName value="sterilizationMethod" /> <short value="Sterilization method" /> </element> <element id="DeviceDefinition.property:sterilizationMethod.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="sterilization-method" /> <display value="Sterilization Method" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:sterilizationMethod.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="CodeableConcept" /> </type> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/SterilizationMethod" /> </binding> </element> <element id="DeviceDefinition.property:layUse"> <path value="DeviceDefinition.property" /> <sliceName value="layUse" /> <short value="Indicates if the device can be used by a lay user" /> <max value="1" /> </element> <element id="DeviceDefinition.property:layUse.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="lay-use" /> <display value="Intended for use by a lay user" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:layUse.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:incorporatesAi"> <path value="DeviceDefinition.property" /> <sliceName value="incorporatesAi" /> <short value="Indicates if the product incorporates AI (artificial intelligence) in any device function" /> <max value="1" /> </element> <element id="DeviceDefinition.property:incorporatesAi.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="incorporates-ai" /> <display value="Incorporates Artificial Inteligence into the medical device function" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:incorporatesAi.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:combinationProduct"> <path value="DeviceDefinition.property" /> <sliceName value="combinationProduct" /> <short value="Indicates if the product is associated with any pharmaceutical product that has a secondary function in the device" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:combinationProduct.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="combination-product" /> <display value="Combination product" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:combinationProduct.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:clinicallyRelevantSizes"> <path value="DeviceDefinition.property" /> <sliceName value="clinicallyRelevantSizes" /> <short value="Specify dimensional characteristics that are relevant for the product's clinical function" /> <max value="1" /> </element> <element id="DeviceDefinition.property:clinicallyRelevantSizes.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="clinically-relevant-sizes" /> <display value="Clinically Relevant Sizes" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:clinicallyRelevantSizes.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="string" /> </type> <maxLength value="5000" /> </element> <element id="DeviceDefinition.property:batchNumber"> <path value="DeviceDefinition.property" /> <sliceName value="batchNumber" /> <short value="Indicates the presence of lot or Batch Number" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:batchNumber.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="batch-number" /> <display value="Lot or Batch Number" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:batchNumber.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:serialNumber"> <path value="DeviceDefinition.property" /> <sliceName value="serialNumber" /> <short value="Indicates the presence of serial number" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:serialNumber.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="serial-number" /> <display value="Serial Number" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:serialNumber.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:expirationDate"> <path value="DeviceDefinition.property" /> <sliceName value="expirationDate" /> <short value="Indicates the presence of expiration date" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:expirationDate.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="expiration-date" /> <display value="Expiration date" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:expirationDate.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:manufRecondReprocDate"> <path value="DeviceDefinition.property" /> <sliceName value="manufRecondReprocDate" /> <short value="Indicates the presence of a Manufacture or Refurbishing/Reprocessing date" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.property:manufRecondReprocDate.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="manuf-recond-reproc-date" /> <display value="Manufacture or Refurbishing/Reprocessing date" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:manufRecondReprocDate.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:samdReleaseDate"> <path value="DeviceDefinition.property" /> <sliceName value="samdReleaseDate" /> <short value="Indicates the presence of SaMD release date" /> <max value="1" /> </element> <element id="DeviceDefinition.property:samdReleaseDate.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="samd-release-date" /> <display value="SaMD release date" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:samdReleaseDate.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.property:samdVersion"> <path value="DeviceDefinition.property" /> <sliceName value="samdVersion" /> <short value="Indicates the presence of SaMD version" /> <max value="1" /> </element> <element id="DeviceDefinition.property:samdVersion.type"> <path value="DeviceDefinition.property.type" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty" /> <version value="1.0.0" /> <code value="samd-version" /> <display value="SaMD version" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.property:samdVersion.value[x]"> <path value="DeviceDefinition.property.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="DeviceDefinition.owner"> <path value="DeviceDefinition.owner" /> <max value="0" /> </element> <element id="DeviceDefinition.contact"> <path value="DeviceDefinition.contact" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <min value="1" /> <max value="2" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo"> <path value="DeviceDefinition.contact" /> <sliceName value="urlForAdditionalInfo" /> <short value="URL for additional information. Fill out whenever the company wants to indicate a URL where additional product information can be found (e.g., company website with product catalog or electronic instructions for use)" /> <max value="1" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo.system"> <path value="DeviceDefinition.contact.system" /> <min value="1" /> <fixedCode value="url" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo.value"> <path value="DeviceDefinition.contact.value" /> <min value="1" /> <maxLength value="5000" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo.use"> <path value="DeviceDefinition.contact.use" /> <max value="0" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo.rank"> <path value="DeviceDefinition.contact.rank" /> <max value="0" /> </element> <element id="DeviceDefinition.contact:urlForAdditionalInfo.period"> <path value="DeviceDefinition.contact.period" /> <max value="0" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo"> <path value="DeviceDefinition.contact" /> <sliceName value="manufacCustomerServiceInfo" /> <short value="Manufacturer’s Customer Service Contact Information (as indicated on the label)" /> <min value="1" /> <max value="1" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo.system"> <path value="DeviceDefinition.contact.system" /> <min value="1" /> <fixedCode value="other" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo.value"> <path value="DeviceDefinition.contact.value" /> <min value="1" /> <maxLength value="5000" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo.use"> <path value="DeviceDefinition.contact.use" /> <max value="0" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo.rank"> <path value="DeviceDefinition.contact.rank" /> <max value="0" /> </element> <element id="DeviceDefinition.contact:manufacCustomerServiceInfo.period"> <path value="DeviceDefinition.contact.period" /> <max value="0" /> </element> <element id="DeviceDefinition.link"> <path value="DeviceDefinition.link" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <max value="2" /> </element> <element id="DeviceDefinition.link:attachedRecord"> <path value="DeviceDefinition.link" /> <sliceName value="attachedRecord" /> <short value="Another registration to which this record is attached" /> <max value="1" /> </element> <element id="DeviceDefinition.link:attachedRecord.relation"> <path value="DeviceDefinition.link.relation" /> <fixedCoding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/RelationType" /> <version value="1.0.0" /> <code value="attached" /> <display value="The current registration is being attached to another" /> </fixedCoding> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/AttachedRelationType" /> </binding> </element> <element id="DeviceDefinition.link:previousRecord"> <path value="DeviceDefinition.link" /> <sliceName value="previousRecord" /> <short value="A previous registration replaced by this record" /> <max value="1" /> </element> <element id="DeviceDefinition.link:previousRecord.relation"> <path value="DeviceDefinition.link.relation" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/PreviousRelationType" /> </binding> </element> <element id="DeviceDefinition.note"> <path value="DeviceDefinition.note" /> <max value="0" /> </element> <element id="DeviceDefinition.material"> <path value="DeviceDefinition.material" /> <slicing> <discriminator> <type value="value" /> <path value="property" /> </discriminator> <rules value="open" /> </slicing> <max value="2" /> </element> <element id="DeviceDefinition.material:biologicMaterial"> <path value="DeviceDefinition.material" /> <sliceName value="biologicMaterial" /> <short value="Indicates if any component of the product has origins in cells, tissues, or their non-viable derivatives (without metabolism or multiplication capability) or made non-viable" /> <max value="1" /> </element> <element id="DeviceDefinition.material:biologicMaterial.substance"> <path value="DeviceDefinition.material.substance" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType" /> <version value="1.0.0" /> <code value="biologic-material" /> <display value="Biological tissues/cells or their derivatives" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.material:biologicMaterial.alternate"> <path value="DeviceDefinition.material.alternate" /> <max value="0" /> </element> <element id="DeviceDefinition.material:biologicMaterial.allergenicIndicator"> <path value="DeviceDefinition.material.allergenicIndicator" /> <max value="0" /> </element> <element id="DeviceDefinition.material:naturalLatex"> <path value="DeviceDefinition.material" /> <sliceName value="naturalLatex" /> <short value="Indicates if the device is labeled as "Contain natural latex. May cause allergy"" /> <max value="1" /> </element> <element id="DeviceDefinition.material:naturalLatex.substance"> <path value="DeviceDefinition.material.substance" /> <fixedCodeableConcept> <coding> <system value="https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType" /> <version value="1.0.0" /> <code value="natural-latex" /> <display value="Natural latex" /> </coding> </fixedCodeableConcept> </element> <element id="DeviceDefinition.material:naturalLatex.alternate"> <path value="DeviceDefinition.material.alternate" /> <max value="0" /> </element> <element id="DeviceDefinition.material:naturalLatex.allergenicIndicator"> <path value="DeviceDefinition.material.allergenicIndicator" /> <min value="1" /> <fixedBoolean value="true" /> </element> <element id="DeviceDefinition.productionIdentifierInUDI"> <path value="DeviceDefinition.productionIdentifierInUDI" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.extension"> <path value="DeviceDefinition.guideline.extension" /> <max value="1" /> </element> <element id="DeviceDefinition.guideline.extension:warningDescription"> <path value="DeviceDefinition.guideline.extension" /> <sliceName value="warningDescription" /> <short value="Additional critical warnings and contraindications for use" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/WarningDescription" /> </type> <isModifier value="false" /> </element> <element id="DeviceDefinition.guideline.useContext"> <path value="DeviceDefinition.guideline.useContext" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.usageInstruction"> <path value="DeviceDefinition.guideline.usageInstruction" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.relatedArtifact"> <path value="DeviceDefinition.guideline.relatedArtifact" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.indication"> <path value="DeviceDefinition.guideline.indication" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.contraindication"> <path value="DeviceDefinition.guideline.contraindication" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.warning"> <path value="DeviceDefinition.guideline.warning" /> <max value="0" /> </element> <element id="DeviceDefinition.guideline.intendedUse"> <path value="DeviceDefinition.guideline.intendedUse" /> <max value="0" /> </element> <element id="DeviceDefinition.correctiveAction"> <path value="DeviceDefinition.correctiveAction" /> <max value="0" /> </element> <element id="DeviceDefinition.chargeItem"> <path value="DeviceDefinition.chargeItem" /> <max value="0" /> </element> </differential> </StructureDefinition>