FDA.reportPublic FDA data

BD BACTEC™ Plus Anaerobic/F Culture Vials

Primary DI
30382904421930
Brand
BD BACTEC™ Plus Anaerobic/F Culture Vials
Company
BECTON, DICKINSON AND COMPANY
Model
442193
Catalog number
442193
Device description
BD BACTEC™ Plus Anaerobic/F Culture Vials
Published
2018-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDBSYSTEM, BLOOD CULTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921133000BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIABd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904421930PackageGS150In Commercial Distribution
60382904421931PackageGS170Not in Commercial Distribution
00382904421939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442193030382904421930
6038290442193160382904421931
00382904421939003829044219393829044219390382904421939

GMDN Terms#

Term, Definition table
TermDefinition
Aerobic blood culture broth IVDA bottle containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen specifically for aerobic culture, analysis, and/or other investigation using a manual or automated method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume25Milliliter

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
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

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Primary DI, Brand, Company table
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