B Medical Systems

Basic Information

• Brand Name: B Medical Systems
• Primary DI: 05450104532443
• Version / Model: ML380CS
• Catalog Number: 991.6789.51
• Company Name: B Medical Systems SARL
• Labeler DUNS: 377142935
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-27
• Public Version: 2
• Public Version Date: 2020-02-12
• Public Version Status: Update
• Public Device Record Key: 8c365c12-c1f6-41f5-869a-201d2efde182
• Distribution End Date: 2020-02-11

Device Description

Laboratory refrigerator/ 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
63325	Laboratory refrigerator/freezer	A mains electricity (AC-powered) appliance designed for the storage of laboratory products, specimens, cultures, reagents and other laboratory materials both at refrigerated temperatures (typically 1° to 6° Celsius) and in a frozen state (typically -18° to -30° Celsius). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05450104532443	GS1

Storage Conditions

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