FDA.report

VACUETTE

Primary DI
29120126131466
Brand
VACUETTE
Company
Greiner Bio-One GmbH
Model
453046
Catalog number
453046
Device description
Urine CCM / Urine STB Set VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer Device (454486+455023+724321)
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OIEUrine collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
29120126131466PackageGS11In Commercial Distribution
19120126131469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2912012613146629120126131466
1912012613146919120126131469

GMDN Terms

TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
303639066
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131459VACUETTE4530454530452025-04-02
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
29120126131008VACUETTE7243257243252024-07-23
39120126131012VACUETTE455043P455043P2024-07-02
39120126130978VACUETTE484493P484493P2024-05-14
39120126130985VACUETTE486073P486073P2024-05-14
39120126130992VACUETTE4860894860892024-05-14
39120017577172Vacuette4845074845072023-12-15
39120017579374Vacuette4845184845182023-12-15
39120049208143Vacuette4845284845282023-12-15
29120049209952Vacuette450161V1450161V12023-12-11
29120049208719Vacuette450081V1450081V12023-12-07
29120049208726Vacuette450082V1450082V12023-12-07
29120049208740Vacuette450084V1450084V12023-12-07
39120049208754Vacuette450095V1450095V12023-12-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00382903649341BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
29120126131404VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131411VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131428VACUETTEGreiner Bio-One GmbHOIE2026-01-26
00382903649327BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00810185250554TherapakTherapak LLCOIE2025-08-11
00850024881846LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)PRIVAPATH DIAGNOSTICS LIMITEDOIE2025-07-07
00840117338029LabChoice Midstream Specimen Catch Kit, SterileDynarex CorporationOIE2025-03-14
00860013362904RTL Urine Collection KitRealtime Laboratories, Inc.OIE2025-02-28
G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
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05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
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04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
04580455981025Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
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00860010959206US Biotek LaboratoriesU.S. Biotek Laboratories LLCOIE2023-09-15
00810040820625Cue Sample Collection Kit Cue Health Inc.OIE2023-02-27
00860193001761UroMap Specimen Collection KitCAREDX, INC.OIE2023-02-10
07312058462642TherapakTherapak LLCOIE2022-12-21
00860009877917RenalytixAI Urine Collection KitRenalytix Ai, Inc.OIE2022-05-06
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)PRIVAPATH DIAGNOSTICS LIMITEDOIE2022-03-30
20193489105787MedlineMEDLINE INDUSTRIES, INC.OIE2022-02-17
00653160288414CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOIE2022-01-02
40080196997443MedlineMEDLINE INDUSTRIES, INC.OIE2021-10-29
40080196032007MedlineMEDLINE INDUSTRIES, INC.OIE2021-08-21
40080196031987MEDLINEMEDLINE INDUSTRIES, INC.OIE2021-05-24
00850017881167RecopadMedfire Innovations Inc.OIE2021-05-20
00850017881181RecopadMedfire Innovations Inc.OIE2021-05-20