Home GUDID 04260647540017
TCmatt
Primary DI 04260647540017
Brand TCmatt
Company Tec Com Medizintechnik GmbH
Model NEOsingle
Catalog number 6427401
Device description Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Published 2020-11-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true
Product Codes# Code, Name table Code Name FOH Mattress, Water, Temperature Regulated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FOH Mattress, Water, Temperature Regulated General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260647540116 Package GS1 10 In Commercial Distribution 04260647540017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260647540116 04260647540116 4260647540116 04260647540017 04260647540017 4260647540017
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 315215424 Device count 1 Premarket exempt true Combination product true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes#