DEVICE: Universal ThermoWrap™ (07290012127243)

Device Identifier (DI) Information

Universal ThermoWrap™
Adults, 135-152cm, (single)
In Commercial Distribution
500-03153
M.T.R.E. ADVANCED TECHNOLOGIES LTD.
07290012127243
GS1

1
532022530 *Terms of Use
Accessory for the CritiCool/Allon 2001 system. A body wrap connected to the thermoregulation system.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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).
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FDA Product Code

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Product Code Product Code Name
DWJ System, Thermal Regulating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

806affd8-ca9c-4482-89ab-79350e4efbf1
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
27290012127247 12 07290012127243 In Commercial Distribution Box
57290012127248 6 07290012127243 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+2152591020
info@mmi.co.il
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