BD BACTEC™ Platelet Aerobic/F Culture Vials

Basic Information

• Brand Name: BD BACTEC™ Platelet Aerobic/F Culture Vials
• Primary DI: 00382904420536
• Version / Model: 442053
• Catalog Number: 442053
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-05
• Public Version: 2
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 0e9765c8-037a-4176-b333-c850d2f2b2ed

Device Description

Bottle Bactec Platelet Aerobic/F Medium

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
MZC	System, detection, bacterial, for platelet transfusion products	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58556	Culture medium antimicrobial supplement IVD	A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382904420537	GS1	Shelfpack	50	In Commercial Distribution
Primary	00382904420536	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK180211	000
BK200530	000

Storage Conditions

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