FDA.reportPublic FDA data

BD Vacutainer® Urinalysis Cup Kit

Primary DI
50382903649469
Brand
BD Vacutainer® Urinalysis Cup Kit
Company
BECTON, DICKINSON AND COMPANY
Model
364946
Catalog number
364946
Device description
KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
50382903649469PrimaryGS10
00382903649464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290364946950382903649469
00382903649464003829036494643829036494640382903649464

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
001292192
Device count
50
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905167065BD Intelliport5167065167062020-09-30
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

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
00382903649570BD Vacutainer® Urine Complete Cup KitBECTON, 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