B Medical Systems

Basic Information

• Brand Name: B Medical Systems
• Primary DI: 05450104539602
• Version / Model: BF261
• Catalog Number: 991.8346.01
• 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: 2020-02-11
• Public Version Status: Update
• Public Device Record Key: 8e1b940c-8f1c-401d-bf1b-67c36c303adb
• Distribution End Date: 2020-02-10

Device Description

Blood refrigerator/ Plasma 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
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60607	Blood refrigerator/freezer	An electrically-powered device intended to be used to store and/or transport whole blood and/or blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius), or alternatively frozen (-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 (typically stainless steel or synthetic materials) 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	05450104539602	GS1

Storage Conditions

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