B Medical Systems

Basic Information

• Brand Name: B Medical Systems
• Primary DI: 05450104501029
• Version / Model: UF455G
• Catalog Number: 991.7046.**
• Company Name: B Medical Systems SARL
• Labeler DUNS: 377142935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-11
• Public Version: 1
• Public Version Date: 2020-02-19
• Public Version Status: New
• Public Device Record Key: a35a0f4a-7284-4b04-b551-a0b859cc79f8

Device Description

Ultra Low Freezer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRM	Freezer	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40513	Ultralow-temperature laboratory freezer	A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05450104501029	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius