BACT/ALERT® FN PLUS

Basic Information

• Brand Name: BACT/ALERT® FN PLUS
• Primary DI: 03573026596071
• Version / Model: BACT/ALERT® FN PLUS
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-23
• Public Version: 1
• Public Version Date: 2020-05-01
• Public Version Status: New
• Public Device Record Key: c0561ba0-bd42-478f-b379-aa2da6b69484

Device Description

The BACT/ALERT FN Plus Culture Bottles are used for the recovery and detection of anaerobic,facultative anaerobic microorganisms from blood and other normally sterile body fluids

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026357917	GS1		2	In Commercial Distribution
Package	03573026611903	GS1		50	In Commercial Distribution
Primary	03573026596071	GS1

Premarket Submissions

Submission Number	Supplement Number
K121455	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius