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

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• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260647540017 [Primary]

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