ZipThaw™ 202

GUDID 07290115270006

Plasma thawing device

FREMON SCIENTIFIC, INC.

Plasma thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit

• Primary Device ID: 07290115270006
• NIH Device Record Key: c72c2cdf-6066-4a04-8ce3-c1960061cc24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipThaw™ 202
• Version Model Number: 202
• Company DUNS: 081096140
• Company Name: FREMON SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com
• Phone: 5125354930
• Email: yoram@qsitemed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115270006 [Primary]

FDA Product Code

• KZL: Device, Warming. Blood And Plasma

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-06