Common Sub-Domain::Product

: Public Class

Created:	6/22/2007 12:47:08 PM
Modified:	8/14/2019 1:45:43 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{ADDAE49F-E9A0-43e5-A4D2-77A37B1C1E1A}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View BSP: Biospecimen, View CM: Common, View EX: Experiment, View IM: Imaging, Imaging Acquisition, DICOM SR TID 1500 BRIDG Class Diagram, DEPRECATED Old View MB: Molecular Biology, View MB: Molecular Biology, View PR: Protocol Representation, View RG: Regulatory, View SC: Study Conduct, SDTM IG v3.1.3, SDTM Exposure (EX) Domain, SDTM IG v3.2, Product, Subject and ExperimentalUnit Comparison, Oncology & Imaging, Participant Registration, Anatomic Pathology Structured Report (APSR), Specimen Containers & Storage Equipment, Common Data Model Harmonization (CDMH), National Biomedical Imaging Archive (NBIA), National Marrow Donor Program (NMDP)

DEFINITION: A material produced by or resulting from a process. EXAMPLE(S): animal and human drugs; therapeutic biologics; allergenics; cell, tissue and gene therapy products; blood components; blood derivative products; devices; animal (pets and livestock) and human food/feed (medicated and un-medicated); cosmetics; pet treats; dietary supplements [examples from FDA's list of regulated products] Therapeutic devices, software programs, diagnostic or storage equipment, pill bottle, tube rack Natural or Synthesized DNA The HeLa cell line, the HEK-293 cell line OTHER NAME(S): NOTE(S): The term “Product” as a class name in BRIDG is not intended to imply commercial products only, but rather any material that is produced by a process. This includes biologics collected for testing, transplant or replication, as well as tissue that is banked.

Attributes
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
typeCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Ingredient.typeCode
Map:AE=Package.typeCode
Map:AE=Component.typeCode
Map:AE=Product.typeCode
Map:caAERSv2.2=MedicalDevice.deviceType
Map:CTR&Rr2=Contains Matrices
Map:CTR&Rr2=Contains medical device
Map:CTR&Rr2=Other MP
Map:CTR&Rr2=Homeopathic MP
Map:CTR&Rr2=Other MP Specification
Map:CTR&Rr2=Contains Bio-materials
Map:CTR&Rr2=Contains Scaffolds
Map:CTR&Rr2=Device Other
Map:CTR&Rr2=Device implantable
Map:CTR&Rr2=Herbal MP
Map:CTRPv1.0=Cosmetic.typeCode
Map:CTRPv1.0=Drug.typeCode
Map:CTRPv1.0=Product.typeCode
Map:CTRPv1.0=FoodProduct.typeCode
Map:CTRPv1.0=Device.typeCode
Map:CTRPv1.0=Biologic.typeCode
Map:CTRPv3.8=Intervention.typeCode
Map:CTRPv3.8=PlannedSubstanceAdministration.radiationMachineType
Map:CTRRr3=Product.typeCode
Map:CTRv1.0=Product.typeCode
Map:DICOM=Equipment Specification Module - Equipment Modality (0008,0221)
Map:DICOM=Enhanced PET Series Module - Modality (0008,0060)
Map:DICOM=MR Series Module - Modality (0008,0060)
Map:DICOM=General Series Module - Modality (0008,0060)
Map:DICOM=CT Series Module - Modality (0008,0060)
Map:DICOM=Study Level Keys for the Patient Root Query/Retrieve Information Model - Modalities in Study (0008,0061)
Map:HCTv1.0=CDE 2741209:Preparative Regimen.What was the type of preparative regimen monoclonal antibody (MAb)?
Map:HCTv1.0=CDE 2746489:Techniques.Specify other antibody.
Map:HCTv1.0=CDE 2527917:Cell Source.Specify the other hematopoietic stem cell transplant type:
Map:HCTv1.0=CDE 2750847:Preparative Regimen.What was the type of anthracycline preparative regimen?
Map:HCTv1.0=CDE 2730912:Cell Source.What type of hematopoietic stem cell transplant was used?
Map:HCTv1.0=CDE 2705055:Lab Results.Please specify the person for whom this typing is being done:
Map:HCTv1.0=CDE 2741552:Preparative Regimen.What type of radiolabeled monoclonal antibody was used as a preparative regimen?
Map:HCTv1.0=CDE 2693219:Lab Results.Who is being tested for IDMs?
Map:HL7SD=Product.code
Map:ICSRr2=PackagedProduct.code (in R_Product)
Map:ICSRr2=Container.code (in R_Product)
Map:ICSRr2=Substance.code (in R_Product)
Map:ICSRr2=Product.code (in R_Product)
Map:LSDAMv2.2.3Plus=Software.typeCode
Map:LSDAMv2.2.3Plus=PerformedSpecimenEmbedded.embeddingMediumType
Map:LSDAMv2.2.3Plus=InvitroCharacterization.cellType
Map:LSDAMv2.2.3Plus=DefinedSpecimenEmbedded.embeddingMediumType
Map:LSDAMv2.2.3Plus=Container.containerType
Map:LSDAMv2.2.3Plus=Material.typeCode
Map:LSDAMv2.2.3Plus=Product.typeCode
Map:NBIAv6.4=General_Series.modality
Map:SDTM IGv3.2=EC.ECCAT
Map:SDTM IGv3.2=EC.ECSCAT
Map:SDTM IGv3.2=PR.PRCAT
Map:SDTM IGv3.2=PR.PRSCAT

Notes:

DEFINITION: A coded value specifying the kind of product. EXAMPLE(S): veterinary medicine, diagnostic device, tissue, fluid, cell, molecule, protein, clot tube, KEDTA, ACD, sterile specimen cup, data analysis software, instrument controlling software OTHER NAME(S): NOTE(S): All members of a type share similar functions and general characteristics, especially the purpose for which they are used.

Public DSET<CD>
classCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

Map:AE=ProductClass.typeCode
Map:AE=ProductClass
Map:AE=ProductClass.name
Map:CDASHv1.1=CM.CMCLASCD
Map:CDASHv1.1=CM.CMCLAS
Map:CTR&Rr2=Plasma derived MP
Map:CTR&Rr2=IMP ATC Code
Map:CTR&Rr2=Radiopharmaceutical MP
Map:CTR&Rr2=Extractive MP
Map:CTR&Rr2=CAT (committee for Advanced therapies) Classification issued
Map:CTR&Rr2=GMO (Genetically Modified Organism) MP
Map:CTR&Rr2=Combination ATIMP
Map:CTR&Rr2=Tissue Engineered MP
Map:CTR&Rr2=Immunological MP
Map:CTR&Rr2=CAT Classification
Map:CTR&Rr2=Advanced Therapy MP
Map:CTR&Rr2=AS CAS (Chemical Abstract Service) number
Map:CTR&Rr2=Recombinant MP
Map:CTR&Rr2=Somatic cell therapy MP
Map:CTR&Rr2=Gene therapy MP
Map:CTRPv1.0=Cosmetic.classCode
Map:CTRPv1.0=Biologic.classCode
Map:CTRPv1.0=Device.classCode
Map:CTRPv1.0=FoodProduct.classCode
Map:CTRPv1.0=Drug.classCode
Map:CTRPv1.0=Product.classCode
Map:CTRRr3=Product.classCode
Map:CTRv1.0=Product.classCode
Map:DICOM=Equipment Specification Module - Model Specification Sequence (0018,9912) > Manufacturer's Related Model Group (0008,0222)
Map:FDA HL7 SD SD DSTU2012=manufacturedProduct.classCode
Map:FDA HL7 SD SD DSTU2012=ingredient.classCode
Map:HL7SD=Product.classCode
Map:LSDAMv2.2.3Plus=DefinedSpecimenEmbedded.embeddingMediumType
Map:PGx v1.0=PB.PBDRUG
Map:SDTM IGv3.1.1=CM.CMCLAS
Map:SDTM IGv3.1.1=SU.SUCLASCD
Map:SDTM IGv3.1.1=SU.SUCLAS
Map:SDTM IGv3.1.1=CM.CMCLASCD
Map:SDTM IGv3.1.2=SU.SUCLAS
Map:SDTM IGv3.1.2=CM.CMCLASCD
Map:SDTM IGv3.1.2=CM.CMCLAS
Map:SDTM IGv3.1.2=SU.SUCLASCD
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.1.3=SU.SUCLASCD
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.1.3=SU.SUCLAS
Map:SDTM IGv3.1.3=CM.CMCLASCD
Map:SDTM IGv3.1.3=CM.CMCLAS
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.2=TS.(PCLAS) TSVCDVER WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.2=CM.CMCLASCD
Map:SDTM IGv3.2=TS.(PCLAS) TSVALCD WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.2=TS.(PCLAS) TSVALNF WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.2=TS.(PCLAS) TSVAL WHERE TSPARMCD = "PCLAS"
Map:SDTM IGv3.2=CM.CMCLAS
Map:SDTM IGv3.2=SU.SUCLASCD
Map:SDTM IGv3.2=SU.SUCLAS
Map:SDTM IGv3.2=TS.(PCLAS) TSVCDREF WHERE TSPARMCD = "PCLAS"

Notes:

DEFINITION: A coded value specifying a group of products that are homogeneous or generally considered as substitutes for each other. EXAMPLE(S): stents, breakfast cereals, cox-2 inhibitors OTHER NAME(S): NOTE(S): The class is considered as narrow or broad depending on how substitutable the various products are.

Public ST
codeModifiedText

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=Product.codeModifiedText
Map:SDTM IGv3.1.1=CM.CMMODIFY
Map:SDTM IGv3.1.1=SU.SUMODIFY
Map:SDTM IGv3.1.2=SU.SUMODIFY
Map:SDTM IGv3.1.2=CM.CMMODIFY
Map:SDTM IGv3.1.3=SU.SUMODIFY
Map:SDTM IGv3.1.3=CM.CMMODIFY
Map:SDTM IGv3.2=SU.SUMODIFY
Map:SDTM IGv3.2=CM.CMMODIFY

Notes:

DEFINITION: A character string that is a revision of the original text of the product to enable the coding of the text. EXAMPLE(S): If the original text is "aspriin", the CodeModifiedText could be set to "aspirin", so that the text can be successfully coded. OTHER NAME(S): NOTE(S): In the context of BRIDG, text modification occurs a single time for a given instance of originalText.

Public ST.SIMPLE
lotNumberText

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Package.lotNumber
Map:AE=Product.lotNumber
Map:APSRv2.1=hl7:entryRelationship [CDA Supply Container] - hl7:entryRelationship [CDA Supply Container] > hl7:supply > hl7:product > hl7:manufacturedProduct > hl7:manufacturedMaterial > hl7:lotNumberText
Map:caAERSv2.2=CourseAgent.lotNumber
Map:caAERSv2.2=MedicalDevice.lotNumber
Map:CDASHv1.1=EX.EXLOT
Map:CDMHv1.0=Product.lotNumberText
Map:CTOM=AgentOccurrence.lotNumber
Map:CTRPv1.0=Biologic.lotNumberText
Map:CTRPv1.0=FoodProduct.lotNumberText
Map:CTRPv1.0=Cosmetic.lotNumberText
Map:CTRPv1.0=Drug.lotNumberText
Map:CTRv1.0=Product.lotNumberText
Map:ICSRr2=Container.lotNumberText (in R_Product)
Map:ICSRr2=ProductInstance.lotNumberText (in R_Product)
Map:ICSRr2=DeviceInstance.lotNumberText (in R_Product)
Map:LSDAMv2.2.3Plus=Product.lotNumberText
Map:NCI CRF Standard=CDE 62592v3.0: Agent Lot Identifier Number
Map:OMOPv5.2=DRUG_EXPOSURE.lot_number
Map:SDTM IGv3.1.1=EX.EXLOT
Map:SDTM IGv3.1.2=EX.EXLOT
Map:SDTM IGv3.1.3=EX.EXLOT
Map:SDTM IGv3.2=EX.EXLOT
Map:SDTM IGv3.2=EC.ECLOT

Notes:

DEFINITION: An alphanumeric string used to identify a particular batch of the product. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public TS.DATE.FULL
expirationDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Product.expirationDate
Map:CTOM=AgentOccurrence.expirationDate
Map:CTRPv1.0=Product.expirationDate
Map:CTRPv1.0=Drug.expirationDate
Map:CTRPv1.0=FoodProduct.expirationDate
Map:CTRPv1.0=Device.expirationDate
Map:CTRPv1.0=Biologic.expirationDate
Map:CTRPv1.0=Cosmetic.expirationDate
Map:CTRv1.0=Product.expirationDate
Map:ICSRr2=DeviceInstance.expirationTime (in R_Product)
Map:ICSRr2=ProductInstance.expirationTime (in R_Product)
Map:ICSRr2=Product.expirationTime (in R_Product)
Map:LSDAMv2.2.3Plus=Product.expirationDate

Notes:

DEFINITION: The date (and time), assigned by the manufacturer, on which the product should not be used. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
pre1938Indicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Product.pre1938Indicator
Map:CTRPv1.0=Product.pre1938Indicator
Map:CTRPv1.0=Cosmetic.pre1938Indicator
Map:CTRPv1.0=Device.pre1938Indicator
Map:CTRPv1.0=Drug.pre1938Indicator
Map:CTRPv1.0=FoodProduct.pre1938Indicator
Map:CTRPv1.0=Biologic.pre1938Indicator
Map:CTRv1.0=Product.pre1938Indicator

Notes:

DEFINITION: Specifies whether the product qualifies under the 1938 Grandfather Clause, contained in section 20l(p)(l) of the U.S. Federal Food, Drug and Cosmetic Act. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
PerformedStudyAgentTransfer Class	Name: transferringPerformedStudyAgentTransfer	Name: transferredProduct
Details: DESCRIPTION:<br/>Each PerformedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more PerformedStudyAgentTransfer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DefinedStudyAgentTransfer Class	Name: transferringDefinedStudyAgentTransfer	Name: transferredProduct
Details: DESCRIPTION:<br/>Each DefinedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more DefinedStudyAgentTransfer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DefinedProcedure Class	Name: usingDefinedProcedure	Name: usedProduct
Details: DESCRIPTION:<br/>Each DefinedProcedure might use one or more Product. Each Product might be used during one or more DefinedProcedure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProductGroup Class	Name: groupingProductGroup	Name: groupedProduct
Details: DESCRIPTION:<br/>Each ProductGroup always groups one or more Product. Each Product might be grouped by one or more ProductGroup. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedProductTransport Class	Name: usingPerformedProductTransport	Name: usedProduct
Details: DESCRIPTION:<br/>Each PerformedProductTransport might use one or more Product. Each Product might be used during one or more PerformedProductTransport.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyAgent Class	Name: performedStudyAgent	Name: performingProduct
Details: DESCRIPTION:<br/>Each StudyAgent always is a function performed by one Product. Each Product might function as one or more StudyAgent.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProductRelationship Class	Name: sourceProductRelationship	Name: targetProduct
Details: DESCRIPTION:<br/>Each ProductRelationship always has as target one Product. Each Product might be the target for one or more ProductRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedMaterialStorage Class	Name: usingPerformedMaterialStorage	Name: usedProduct
Details: DESCRIPTION:<br/>Each PerformedMaterialStorage might use one or more Product. Each Product might be used during one or more PerformedMaterialStorage.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
PerformedProductProblemDiscovery Class	Name: involvingPerformedProductProblemDiscovery	Name: involvedProduct
Details: DESCRIPTION:<br/>Each PerformedProductProblemDiscovery always focuses on one Product. Each Product might be the focus of one or more PerformedProductProblemDiscovery.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProductRelationship Class	Name: targetProductRelationship	Name: sourceProduct
Details: DESCRIPTION:<br/>Each ProductRelationship always has as source one Product. Each Product might be the source for one or more ProductRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Subject Class	Name: performedSubject	Name: performingProduct
Details: DESCRIPTION:<br/>Each Subject might be a function performed by one Product. Each Product might function as one or more Subject.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ExperimentalUnit Class	Name: performedExperimentalUnit	Name: performingProduct
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one Product. Each Product might function as one or more ExperimentalUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
«DEPRECATED» Submission Class	Name: describingSubmission	Name: describedProduct
Details: DESCRIPTION:<br/>Each Submission always has as subject one Product. Each Product might be the subject for one or more Submission.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Distributor Class	Name: providedDistributor	Name: providingProduct
Details: DESCRIPTION:<br/>Each Distributor always provides one or more Product. Each Product might be provided by one or more Distributor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProcessingSite Class	Name: fabricatedProcessingSite	Name: fabricatingProduct
Details: DESCRIPTION:<br/>Each ProcessingSite always fabricates one or more Product. Each Product might be fabricated by one or more ProcessingSite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedProcedure Class	Name: usingPerformedProcedure	Name: usedProduct
Details: DESCRIPTION:<br/>Each PerformedProcedure might use one or more Product. Each Product might be used during one or more PerformedProcedure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProcessedProduct Class	Name: producingProcessedProduct	Name: producedProduct
Details: DESCRIPTION:<br/>Each ProcessedProduct always produces one Product. Each Product might be produced by one or more ProcessedProduct.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ScheduledSubstanceAdministration Class	Name: usingScheduledSubstanceAdministration	Name: usedProduct
Details: DESCRIPTION:<br/>Each ScheduledSubstanceAdministration might use one or more Product. Each Product might be used during one or more ScheduledSubstanceAdministration.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	Ingredient
Details:
Map:AE	Product
Details:
Map:AE	Component
Details:
Map:APSRv2.1	hl7:entryRelationship [CDA Supply Container] - hl7:entryRelationship [CDA Supply Container] > hl7:supply > hl7:product > hl7:manufacturedProduct > hl7:manufacturedMaterial
Details:
Map:APSRv2.1	hl7:entryRelationship [CDA Supply Container] - hl7:entryRelationship [CDA Supply Container] > hl7:supply > hl7:product > hl7:manufacturedProduct
Details:
Map:caAERSv2.2	CourseAgent
Details:
Map:caAERSv2.2	StudyParticipantPriorTherapyAgent
Details:
Map:caAERSv2.2	PriorTherapyAgent
Details:
Map:caAERSv2.2	Agent
Details:
Map:caAERSv2.2	ConcomitantMedication
Details:
Map:CDMHv1.0	Product
Details:
Map:CTRPv1.0	Product
Details:
Map:CTRRr3	Product
Details:
Map:CTRv1.0	Product
Details:
Map:HL7SD	Product
Details:
Map:HL7SP	Product
Details:
Map:ICSRr2	Container (in R_Product)
Details:
Map:ICSRr2	ProductInstance (in R_Product)
Details:
Map:ICSRr2	Product (in R_Product)
Details:
Map:ICSRr2	InstanceOfKind (in R_Product)
Details:
Map:ICSRr2	ManufacturedProduct (in R_Product)
Details:
Map:ICSRr2	Substance (in R_Product)
Details:
Map:ICSRr2	product (in A_ProductReportingRelevantInformation)
Details:
Map:LSDAMv2.2.3Plus	Product
Details:

Constraint	Type	Status
Distributor Qualifier	Invariant	Approved
Details: If Product.actualIndicator = "true", then the upper limit is 1 on the Distributor association.<br/>
Processor Qualifier	Invariant	Approved
Details: If Product.actualIndicator = "true", then the upper limit is 1 on the Processor association.<br/>
ProcessingSite Qualifier	Invariant	Approved
Details: If Product.actualIndicator = "true", then the upper limit is 1 on the ProcessingSite association.<br/>
Attribute Set actualIndicator Qualifier	Invariant	Approved
Details: effectiveDateRange, codeModifiedText, lotNumberText, expirationDate are valid only when actualIndicator = "true".<br/>

Object	Type	Connection	Direction	Notes
ProductGroup	Class	Weak	From	DESCRIPTION: Each ProductGroup always groups one or more Product. Each Product might be grouped by one or more ProductGroup. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Material	Class	Generalization	To	DESCRIPTION: Each Product always specializes one Material. Each Material might be specialized by one Product. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
FoodProduct	Class	Generalization	From	DESCRIPTION: Each FoodProduct always specializes one Product. Each Product might be specialized by one FoodProduct. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Cosmetic	Class	Generalization	From	DESCRIPTION: Each Cosmetic always specializes one Product. Each Product might be specialized by one Cosmetic. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Device	Class	Generalization	From	DESCRIPTION: Each Device always is specialized by one Product. Each Product might be specialized by one Device. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Container	Class	Generalization	From	DESCRIPTION: Each Package always specializes one Product. Each Product might be specialized by one Package. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Drug	Class	Generalization	From	DESCRIPTION: Each Drug always specializes one Product. Each Product might be specialized by one Drug. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Biologic	Class	Generalization	From	DESCRIPTION: Each Biologic always specializes one Product. Each Product might be specialized by one Biologic. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):