FDA.reportPublic FDA data

BD Vacutainer® Urine Complete Cup Kit

Primary DI
00382903649570
Brand
BD Vacutainer® Urine Complete Cup Kit
Company
BECTON, DICKINSON AND COMPANY
Model
364957
Catalog number
364957
Device description
KIT URIN COMP 13X75 C&S 16X100 CONI UAP
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JTWSYSTEM, TRANSPORT, AEROBIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTWSystem, Transport, AerobicMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903649575PackageGS150In Commercial Distribution
00382903649570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290364957550382903649575
00382903649570003829036495703829036495700382903649570

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated urine specimen container IVD, preservativeA covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
001292192
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055650LSL HEALTHCARELSL Industries, LLCJTW2025-06-06
30382902900208BD Sputum Collection SystemBECTON, DICKINSON AND COMPANYJTW2024-11-19
00382902900207BD Sputum Collection SystemBECTON, DICKINSON AND COMPANYJTW2024-11-19
30382903649908BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-10
50382903649902BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-10
30382903649441BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
30382903649595BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
30382903649915BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649445BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649599BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649919BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649759BD Vacutainer® Urine Collection CupsBECTON, DICKINSON AND COMPANYJTW2024-04-05
50382903649575BD Vacutainer® Urine Complete Cup KitBECTON, DICKINSON AND COMPANYJTW2024-04-05
00382903649754BD Vacutainer® Urine Collection CupsBECTON, DICKINSON AND COMPANYJTW2024-04-05
05060259070457Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
05060259076046Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
25060259070451Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
15060259076043Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
30382903650171BD Vacutainer® Urinalysis Preservative Urine TubeBECTON, DICKINSON AND COMPANYJTW2023-09-08
28053326000236eSwab™ COPAN ITALIA SPAJTW2023-06-14
38053326000233eSwab™ COPAN ITALIA SPAJTW2023-06-14
38053326009526eSwab™ COPAN ITALIA SPAJTW2023-05-11
68053326009527eSwab™ COPAN ITALIA SPAJTW2023-05-11
50382903649667BD Vacutainer® Urine Transfer StrawBECTON, DICKINSON AND COMPANYJTW2023-03-15
30382903649434BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2023-03-15
30382903649663BD Vacutainer® Urine Transfer StrawBECTON, DICKINSON AND COMPANYJTW2023-03-15
28053326000014eSwab™ COPAN ITALIA SPAJTW2022-12-07
28053326000021eSwab™ COPAN ITALIA SPAJTW2022-12-07
28053326000144eSwab™ COPAN ITALIA SPAJTW2022-12-07
28053326000168eSwab™ COPAN ITALIA SPAJTW2022-12-07