BD BACTEC™ Supplement/F Media Supplement

Basic Information

• Brand Name: BD BACTEC™ Supplement/F Media Supplement
• Primary DI: 30382904421893
• Version / Model: 442189
• Catalog Number: 442189
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 3
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: ce73205d-5f4e-49d1-93ce-771b99dfe081
• Distribution End Date: 2021-07-29

Device Description

BD BACTEC™ Supplement/F Media Supplement

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
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
Primary	30382904421893	GS1
Unit of Use	00382904421892	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K946268	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius