CytoTherm

GUDID 00861128000330

Plasma Thawing System

CYTOTHERM LP

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: 00861128000330
• NIH Device Record Key: 0ca59fdd-0f8a-41ff-a1cf-aa9a168565e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CytoTherm
• Version Model Number: CT-D4
• Company DUNS: 057143901
• Company Name: CYTOTHERM LP
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861128000330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060027

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [CytoTherm]

• 00861128000354: Plasma Thawing System
• 00861128000347: Plasma Thawing System
• 00861128000330: Plasma Thawing System
• 00861128000323: Plasma Thawing System
• 00861128000316: Plasma Thawing System
• 00861128000309: Plasma Thawing System