FDA.reportPublic FDA data

BD BBL™ Chopped Meat Carbohydrate Broth, PR II

Primary DI
30382902973073
Brand
BD BBL™ Chopped Meat Carbohydrate Broth, PR II
Company
BECTON, DICKINSON AND COMPANY
Model
297307
Catalog number
297307
Device description
BD BBL™ Chopped Meat Carbohydrate Broth, PR II, 5 mL, Package 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
30382902973073PrimaryGS10
00382902973072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290297307330382902973073
00382902973072003829029730723829029730720382902973072

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00This way up
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
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
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