FDA.reportPublic FDA data

BD Vacutainer® C&S Boric Acid Kit

Primary DI
50382903649599
Brand
BD Vacutainer® C&S Boric Acid Kit
Company
BECTON, DICKINSON AND COMPANY
Model
364959
Catalog number
364959
Device description
KIT URIN TRANSTR 13X75 C&S KAGN CE HEMO
Published
2024-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50382903649599PackageGS14In Commercial Distribution
30382903649595PrimaryGS10
00382903649594Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290364959950382903649599
3038290364959530382903649595
00382903649594003829036495943829036495940382903649594

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

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903935314Nexiva3935313935312026-07-30
00382903935321Nexiva3935323935322026-07-30
00382903935338Nexiva3935333935332026-07-30
00382903935345Nexiva3935343935342026-07-30
00382903935352Nexiva3935353935352026-07-30
00382903935369Nexiva3935363935362026-07-30
00382903935376Nexiva3935373935372026-07-30
00382903935383Nexiva3935383935382026-07-30
00885403523000FOGARTY SOFTJAWCSOFT6CSOFT62026-07-30
00885403523161FOGARTY HYDRAJAWHYDRA33HYDRA332026-07-30
00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
00885403523277FOGARTY SOFTJAWSOFT86SOFT862026-07-30
00885403529637Acumen IQAIQCAAIQCA2026-07-29
00885403529668Acumen IQAIQCSAIQCS2026-07-29
00885403529774ClearSight JrCSCJR1CSCJR12026-07-29
00885403529781ClearSightCSCLCSCL2026-07-29
00885403529798ClearSightCSCMCSCM2026-07-29
00885403529811ClearSightCSCSCSCS2026-07-29
00885403529828VitaWaveVWCAVWCA2026-07-29
00885403522393Swan-Ganz834F75834F752026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576901515Puritan® OptiSwab®Puritan Medical ProductsJTW2026-07-08
00609576901713Puritan® OptiSwab®Puritan Medical ProductsJTW2026-07-08
00609576901775Puritan® OptiSwab®Puritan Medical ProductsJTW2026-07-08
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
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