TCmatt

Basic Information

• Brand Name: TCmatt
• Primary DI: 04260647540017
• Version / Model: NEOsingle
• Catalog Number: 6427401
• Company Name: Tec Com Medizintechnik GmbH
• Labeler DUNS: 315215424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-20
• Public Version: 1
• Public Version Date: 2020-11-30
• Public Version Status: New
• Public Device Record Key: 4ede8996-c57d-4f18-8296-ef02496181c7

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOH	Mattress, Water, Temperature Regulated	General Hospital	880.5560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63182	Neonatal hypothermia cot heat-conduction mattress	A non-sterile, patient-contact component of a neonatal hypothermia cot assembly intended to be used during induction of mild hypothermia in a neonatal patient by allowing heat transfer away from the recumbent patient. It is typically gel-filled and intended to be placed between the patient and a cooled heat-retention pad. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260647540017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]