BD BACTEC™ Plus Anaerobic/F Culture Vials

Basic Information

• Brand Name: BD BACTEC™ Plus Anaerobic/F Culture Vials
• Primary DI: 00382904421939
• Version / Model: 442193
• Catalog Number: 442193
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 3
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 1bfcc54c-9ae5-4820-b94f-5468e768f023
• Distribution End Date: 2023-07-07

Device Description

Bactec Plus Anaerobic/F 50/Pk F/G

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDB	SYSTEM, BLOOD CULTURING	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58543	Blood culture broth kit IVD	A collection of two or more bottles 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 for culture, analysis, and/or other investigation using a manual or automated method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382904421930	GS1	Shelfpack	50	Not in Commercial Distribution	2023-07-07
Primary	00382904421939	GS1
Package	60382904421931	GS1	US pallet	70	Not in Commercial Distribution	2023-07-07

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius