B Medical Systems

Basic Information

• Brand Name: B Medical Systems
• Primary DI: 05450104537523
• Version / Model: P380
• Catalog Number: 991.8336.03
• 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: 7b02e76d-d44d-45d1-bd56-36664cdbe9ad
• Distribution End Date: 2020-02-10

Device Description

Pharmacy 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
JRM	Freezer	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17156	Pharmacy refrigerator	A mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05450104537523	GS1

Storage Conditions

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