DEVICE: CureWrap™ Pediatric 104–122cm (single) (07290012127373)
Device Identifier (DI) Information
CureWrap™ Pediatric 104–122cm (single)
500-03541
In Commercial Distribution
500-03541
BELMONT INSTRUMENT CORPORATION
500-03541
In Commercial Distribution
500-03541
BELMONT INSTRUMENT CORPORATION
Accessory for the CritiCool system.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36956 | External circulating-fluid core temperature regulation system control unit, heating/cooling |
An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s 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).
|
Active | false |
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
68624a13-b1c6-4760-b854-5b664fa17094
December 18, 2023
5
September 24, 2016
December 18, 2023
5
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 |
---|---|---|---|---|---|
17290012127370 | 8 | 07290012127373 | In Commercial Distribution | Box | |
77290012127372 | 4 | 07290012127373 | 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