FDA.reportPublic FDA data

BD Vacutainer Urine Complete Cup Kit

Primary DI
00382903649341
Brand
BD Vacutainer Urine Complete Cup Kit
Company
BECTON, DICKINSON AND COMPANY
Model
364934
Catalog number
364934
Device description
KIT URINCOL 13x75C&S16x100CONUA16x100UA
Published
2026-02-03
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

Product Codes#

Code, Name table
CodeName
OIEUrine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903649346PrimaryGS10
00382903649341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290364934650382903649346
00382903649341003829036493413829036493410382903649341

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
50
DM exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160518397MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OIE2026-04-07
50382903649346BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
19120126131407VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131414VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131421VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131469VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131404VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131411VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131428VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131466VACUETTEGreiner Bio-One GmbHOIE2026-01-26
50382903649322BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00382903649327BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00810185250547TherapakTherapak LLCOIE2025-08-11
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
G7327021Everlywell Blood and Urine Collection KitEverly Health, Inc.OIE2025-02-18
G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
10860009616032Kidney Stone Transportation KitDitek Consulting, LLCOIE2024-11-19
05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
00850054552051US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
10850054552058US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
04580455981025Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
00810113420028INDICAID health Sexual Health 2Phase Diagnostics, Inc.OIE2023-10-03
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