B Medical Systems

Basic Information

• Brand Name: B Medical Systems
• Primary DI: 05450104061837
• Version / Model: MT100
• Catalog Number: 991.2370.**
• Company Name: B Medical Systems SARL
• Labeler DUNS: 377142935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-08
• Public Version: 1
• Public Version Date: 2022-06-16
• Public Version Status: New
• Public Device Record Key: 6a500af0-52ae-4e01-bb17-e3fb71c87af1

Device Description

Blood storage refrigerator

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
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63461	Blood refrigerator/incubator	An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (from 1° to 6° Celsius), or alternatively warm (from 20° to 24° Celsius). It may include an active system to regulate the temperature (e.g., compressor), handles and/or wheels for transportation, and alarms which signal unintentional changes in temperature and power failures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05450104061837	GS1

Storage Conditions

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