Home GUDID 07290012127243 Universal ThermoWrap™
Primary DI 07290012127243
Brand Universal ThermoWrap™
Company M.T.R.E. ADVANCED TECHNOLOGIES LTD.
Model Adults, 135-152cm, (single)
Catalog number 500-03153
Device description Accessory for the CritiCool/Allon 2001 system. A body wrap connected to the thermoregulation system.
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DWJ System, Thermal Regulating
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWJ System, Thermal Regulating Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 27290012127247 Package GS1 12 In Commercial Distribution 57290012127248 Package GS1 6 In Commercial Distribution 07290012127243 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 27290012127247 27290012127247 57290012127248 57290012127248 07290012127243 07290012127243 7290012127243
GMDN Terms# Term, Definition table Term Definition Circulating-fluid whole-body heating/cooling system control unit A mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body heating/cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for heating and alternatively cooling a patient’s whole-body (i.e., elevate or lower core body temperature). The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).
Regulatory Flags# DUNS number 532022530 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290102932313 CritiCool Pro VitaLogik4000 3/5Lead,NI Nellcor Blue 681-0R0-013 2016-09-24 07290102932337 CritiCool Pro VitaLogik4000 3/5Lead,NI Masimo Blue 681-0R0-023 2016-09-24 07290102932344 CritiCool Pro VitaLogik4500 3/5Lead Nellcor Blue 681-0R0-113 2016-09-24 07290107580526 CritiCool Pro VL4000N 115VAC 100-00013 2016-09-24 07290107580540 CritiCool Pro VL4000M 115VAC 100-00113 2016-09-24 07290107580564 CritiCool Pro VL4500N 115VAC 100-00213 2016-09-24 07290107580588 CritiCool Pro VL4500M 115VAC 100-00313 2016-09-26 07290012127175 CureWrap™ One Size for all Adults (single) 500-03500 2016-09-24 07290012127182 CureWrap™ Infant, Up to 4Kg 500-03518 2016-09-24 07290012127199 CureWrap™ Infant, 4-7Kg (single) 500-03521 2016-09-24 07290012127205 ThermoWrap™ Pediatric, 79–91cm (single) 500-03131 2016-09-24 07290012127212 ThermoWrap™ Pediatric , 91–104cm (single) 500-03136 2016-09-24 07290012127229 ThermoWrap™ Pediatric, 104–122cm (single) 500-03141 2016-09-24 07290012127236 ThermoWrap™ Pediatric, 122–135cm, (single) 500-03148 2016-09-24 07290012127250 ThermoWrap™ Universal, Adults, 152-168cm (single) 500-03160 2016-09-24 07290012127267 ThermoWrap™ Universal, Adults, 168-189cm, (single) 500-03166 2016-09-24 07290012127274 ThermoWrap™ Cardiac, Adults, 165-172cm, (single) 500-03363 2016-09-24 07290012127281 ThermoWrap™ Infant, 2.5–4.0Kg,(single) 500-03118 2016-09-24 07290012127298 ThermoWrap™ Infant, 4.0–7.0Kg, (single) 500-03121 2016-09-24 07290012127304 ThermoWrap™ Infant, 7.0–11Kg, (single) 500-03125 2016-09-24
Other Devices Sharing Product Codes# 
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