TCmatt 6427401

GUDID 04260647540017

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.

Tec Com Medizintechnik GmbH

Neonatal hypothermia cot heat-conduction mattress

• Primary Device ID: 04260647540017
• NIH Device Record Key: 4ede8996-c57d-4f18-8296-ef02496181c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCmatt
• Version Model Number: NEOsingle
• Catalog Number: 6427401
• Company DUNS: 315215424
• Company Name: Tec Com Medizintechnik GmbH
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260647540017 [Primary]
GS1	04260647540116 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• FOH: Mattress, Water, Temperature Regulated

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [TCmatt]

• 04260647540017: Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of p
• 04260647540031: Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of p