B Medical Systems 991.8336.01

GUDID 05450104537509

Blood storage refrigerator

B Medical Systems SARL

Blood refrigerator

• Primary Device ID: 05450104537509
• NIH Device Record Key: 18b65692-7e1d-49f4-a340-e19927c8933a
• Commercial Distribution Discontinuation: 2020-02-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: B Medical Systems
• Version Model Number: B381
• Catalog Number: 991.8336.01
• 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	05450104537509 [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: 2018-09-27

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• 05450104543920: Ultra Low Freezer
• 05450104543906: Ultra Low Freezer
• 05450104543883: Ultra Low Freezer
• 05450104543869: Ultra Low Freezer
• 05450104543791: Blood storage refrigerator
• 05450104543777: Blood storage refrigerator
• 05450104543760: Blood storage refrigerator
• 05450104543739: Blood storage refrigerator
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• 05450104543685: Laboratory refrigerator
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• 05450104543647: Plasma storage freezer
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• 05450104543609: Laboratory freezer
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• 05450104542725: Laboratory freezer
• 05450104542695: Pharmacy refrigerator
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• 05450104542657: Pharmacy refrigerator
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