FDA.reportPublic FDA data

BD BACTEC™ Standard Anaerobic/F Culture Vials

Primary DI
30382904420247
Brand
BD BACTEC™ Standard Anaerobic/F Culture Vials
Company
BECTON, DICKINSON AND COMPANY
Model
442024
Catalog number
442024
Device description
BD BACTEC™ Standard Anaerobic/F Culture Vials, case of 50 vials
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
MDBSYSTEM, BLOOD CULTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161306000BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson2016-08-08MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904420247PackageGS150In Commercial Distribution
60382904420248PackageGS180In Commercial Distribution
00382904420246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442024730382904420247
6038290442024860382904420248
00382904420246003829044202463829044202460382904420246

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 Volume40Milliliter

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
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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