HemoCool Gel-Pak 8100

GUDID M74481001

BIOSYNERGY, INC.

Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable Hot/cold therapy pack, reusable

• Primary Device ID: M74481001
• NIH Device Record Key: 0c35b892-721d-4b02-8e32-2feff178602f
• Commercial Distribution Discontinuation: 2022-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HemoCool Gel-Pak
• Version Model Number: 8100
• Catalog Number: 8100
• Company DUNS: 070698154
• Company Name: BIOSYNERGY, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

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	M74481000 [Primary]
HIBCC	M74481001 [Package]; Contains: M74481000; Package: Case [6 Units]; Discontinued: 2022-02-12; Not in Commercial Distribution

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: 3
• Public Version Date: 2022-05-12
• Device Publish Date: 2018-01-10

Devices Manufactured by BIOSYNERGY, INC.

• M74420002 - HemoTemp: 2022-05-12
• M74450002 - StaFreez: 2022-05-12
• M74481001 - HemoCool Gel-Pak: 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