FDA.reportPublic FDA data

Colli-Pee

Primary DI
00627595001627
Brand
Colli-Pee
Company
DNA Genotek Inc
Model
Colli-Pee FV-5020
Catalog number
N00055
Device description
Urine Collection Container
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595001627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595001627006275950016276275950016270627595001627

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207983508
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627595000279Oragene DxOXD-5002025-09-08
00627595000286Oragene DxOYD-5002025-09-08
00627595001634Colli-PeeColli-Pee FV-5010N003092024-12-09
00627595001641Colli-PeeColli-Pee FV-5020cN002382024-12-09
00627595001658Colli-PeeColli-Pee FV-5004N002902024-12-09
00627595001665Colli-PeeColli-Pee FV-5040N002692024-12-09
00627595001672Colli-PeeColli-Pee UCM FV-5020N001762024-12-09
00627595001689Colli-PeeColli-Pee UCM FV-5010N003272024-12-09
00627595001696Colli-PeeColli-Pee UCM FV-5003bN003832024-12-09
00627595001702Colli-PeeColli-Pee UCM FV-5004N002602024-12-09
00627595001719Colli-PeeColli-Pee UAS FV-5040N003422024-12-09
00627595000507OMNIgene GUT DxOMD-2002022-11-18
00627595000712ORAcollect DxOCD-100.0142022-11-18
00627595000132Oragene DxOGD-5102016-09-08
00627595000248Oragene DxOGD-6002016-09-09
00627595000255Oragene DxOGD-6102016-09-09
00627595000309ORAcollect DxOCD-1002016-09-10
00627595000682Accessory SpongesOG-AC12022-11-21
00627595000316ORAcollect DxOCD-100A2022-11-18
00627595000675OMNIgene ORALOME-5052022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
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00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
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