DEVICE: CureWrap™ (07290107580212)
Device Identifier (DI) Information
CureWrap™
Pediatric 104-122cm (single)
In Commercial Distribution
PED-L2001
M.T.R.E. ADVANCED TECHNOLOGIES LTD.
Pediatric 104-122cm (single)
In Commercial Distribution
PED-L2001
M.T.R.E. ADVANCED TECHNOLOGIES LTD.
Accessory connected to the CritiCool system. A body wrap connected to the CritiCool.
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). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWJ | System, Thermal Regulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
00b3a5f3-1140-4d8b-bd21-0164083ddb0b
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
77290107580211 | 4 | 07290107580212 | In Commercial Distribution | Box | |
17290107580080 | 8 | 07290107580212 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+2152591020
info@mmi.co.il
info@mmi.co.il