BD BACTEC™ FOS™ (Fastidious Organism Supplement) Kit

Basic Information

• Brand Name: BD BACTEC™ FOS™ (Fastidious Organism Supplement) Kit
• Primary DI: 30382904421534
• Version / Model: 442153
• Catalog Number: 442153
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 21c910ca-99bb-4b9d-964e-bb1c52d427dd

Device Description

BD BACTEC™ FOS™ (Fastidious Organism Supplement) Kit

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
58603	Fastidious-microorganism antimicrobial susceptibility culture medium IVD	A supplemented culture medium enriched with blood and/or other additives intended to be used to perform diagnostic antimicrobial susceptibility testing on fastidious microorganisms isolated from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904421534	GS1
Unit of Use	00382904421533	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920933	000

Storage Conditions

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