StaFreez

GUDID M74450002

BIOSYNERGY, INC.

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• Primary Device ID: M74450002
• NIH Device Record Key: b9e62b61-ba41-498a-841d-12e01018525d
• Commercial Distribution Discontinuation: 2022-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: StaFreez
• Version Model Number: 5000
• Company DUNS: 070698154
• Company Name: BIOSYNERGY, INC.
• Device Count: 50
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M74450000 [Unit of Use]
HIBCC	M74450001 [Primary]
HIBCC	M74450002 [Package]; Contains: M74450001; Package: Case [5 Units]; Discontinued: 2022-02-12; Not in Commercial Distribution

FDA Product Code

• JRR: Regulator, Temperature

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-05-12
• Device Publish Date: 2017-06-01

Devices Manufactured by BIOSYNERGY, INC.

• M74420002 - HemoTemp: 2022-05-12
• M74450002 - StaFreez: 2022-05-12
• M74450002 - StaFreez: 2022-05-12
• M74481001 - HemoCool Gel-Pak: 2022-05-12
• M74490001 - HemoTemp II Activator: 2022-05-12
• M74430001 - HemoTemp II: 2021-03-01
• M74460002 - LabTemp 20: 2021-03-01
• M74461001 - LabTemp 40: 2021-03-01
• M74410002 - TempTrend: 2020-02-24