B Medical Systems 991.8216.**

GUDID 05450104543739

Blood storage refrigerator

B Medical Systems SARL

Blood refrigerator

• Primary Device ID: 05450104543739
• NIH Device Record Key: ef480533-fc9a-4259-8abf-dd1330e4e2c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B Medical Systems
• Version Model Number: B501
• Catalog Number: 991.8216.**
• Company DUNS: 377142935
• Company Name: B Medical Systems SARL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05450104543739 [Primary]

FDA Product Code

• KSE: Refrigerator, Freezer, Blood Storage

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-11
• Device Publish Date: 2019-02-08

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