FDA.reportPublic FDA data

Colli-Pee

Primary DI
05404034700014
Brand
Colli-Pee
Company
Novosanis
Model
Colli-Pee FV-5020
Catalog number
N00055
Device description
Urine Collection Container
Published
2023-05-11
Public version status
Update
Distribution status
Not 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
05404034700014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404034700014054040347000145404034700014

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] 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, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. 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
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400876409
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404034700021Colli-PeeColli-Pee FV-5010N003092023-05-11
05404034700038Colli-PeeColli-Pee FV-5020cN002382023-05-11
05404034700045Colli-PeeColli-Pee FV-5004N002902023-05-11
05404034700052Colli-PeeColli-Pee FV-5040N002692023-05-11
05404034700069Colli-PeeColli-Pee UCM FV-5020N001762023-05-11
05404034700076Colli-PeeColli-Pee UCM FV-5010N003272023-05-11
05404034700083Colli-PeeColli-Pee UCM FV-5003bN003832023-05-11
05404034700090Colli-PeeColli-Pee UCM FV-5004N002602023-05-11
05404034700106Colli-PeeColli-Pee UAS FV-5040N003422023-05-11
54040347000104Colli-PeeColli-Pee UAS FV-5040N003422023-01-05
54040347000036Colli-PeeColli-Pee FV-5020cN002382023-03-06
54040347000012Colli-PeeColli-Pee FV-5020N000552022-12-06
54040347000029Colli-PeeColli-Pee FV-5010N003092022-12-06
54040347000043Colli-PeeColli-Pee FV-5004N002692022-12-06
54040347000050Colli-PeeColli-Pee FV-5040N002692022-12-06
54040347000067Colli-PeeColli-Pee UCM FV-5020N001762022-12-06
54040347000074Colli-PeeColli-Pee UCM FV-5010N003272022-12-06
54040347000081Colli-PeeColli-Pee UCM FV-5003bN003832022-12-06
54040347000098Colli-PeeColli-Pee UCM FV-5004N003422022-12-06

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Primary DI, Brand, Company table
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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
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