GUDID 04260498580002

TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung

Circulating-fluid whole-body heating/cooling system control unit External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling

• Primary Device ID: 04260498580002
• NIH Device Record Key: c0172f10-1b3f-4bb6-b926-b1f3d7aca60d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TECOTHERM NEO
• Company DUNS: 315496666
• Company Name: TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260498580002 [Primary]

FDA Product Code

• DWJ: System, Thermal Regulating

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: 2016-12-01