FDA.reportPublic FDA data

BD BBL™ Chopped Meat Glucose Broth, Pre-reduced II

Primary DI
30382902973059
Brand
BD BBL™ Chopped Meat Glucose Broth, Pre-reduced II
Company
BECTON, DICKINSON AND COMPANY
Model
297305
Catalog number
297305
Device description
BD BBL™ Chopped Meat Glucose Broth, PR II, Pkg. of 10 size K tubes
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSLCULTURE MEDIA, ANAEROBIC TRANSPORT
KZICULTURE MEDIA, ENRICHED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSLCulture Media, Anaerobic TransportMicrobiology1
KZICulture Media, EnrichedMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770840000PRE-REDUCED ANAEROBIC MEDIAGibco Laboratories Life Technologies, Inc.1977-06-08JSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902973059PrimaryGS10
00382902973058Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290297305930382902973059
00382902973058003829029730583829029730580382902973058

GMDN Terms#

Term, Definition table
TermDefinition
Anaerobic broth culture medium IVDA supplemented broth culture medium intended to be used to sustain and enhance the growth of anaerobic or other fastidious microorganisms in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840165400402Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400426Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400440Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400419Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400433Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400457Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00842558116419ACT I Transport PK/10REMEL, INC.JSL2024-08-06
00842558116426ACT II Transport PK/10REMEL, INC.JSL2024-08-06
00842558116433ACT II Dual Transport PK/10REMEL, INC.JSL2024-08-06
00850056467063Schaedler Blood Agar OxyPlateOxyrase, Inc.KZI2023-11-30
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911144RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
38053326002077 CultureSwab™ MaxV(+)COPAN ITALIA SPAJSL2023-06-14
58053326002071 CultureSwab™ MaxV(+)COPAN ITALIA SPAJSL2023-06-14
38053326001919BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
38053326009823Transystem™ COPAN ITALIA SPAJSL2023-03-03
58053326001913BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
58053326009827Transystem™ COPAN ITALIA SPAJSL2023-03-03
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
05051716000162AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
28053326000588Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000595Transystem™ COPAN ITALIA SPAJSL2022-12-07