QuickThaw®

GUDID 00816394020650

Plasma Thawing System

HELMER, INC.

Plasma thawing unit Plasma thawing unit 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: 00816394020650
• NIH Device Record Key: e0b1697d-6e75-49ea-8123-fd2f3423ba9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickThaw®
• Version Model Number: DH8
• Company DUNS: 086685682
• Company Name: HELMER, INC.
• 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

Customer Support Contacts

• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816394020650 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2018-03-29
• Device Publish Date: 2016-07-01

On-Brand Devices [QuickThaw®]

• 00816394020667: Plasma Thawing System
• 00816394020650: Plasma Thawing System
• 00816394020643: Plasma Thawing System