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

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00885403523598VAMP48VMP12048VMP1202026-07-31
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00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
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00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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