DEVICE: ThermoWrap™ Universal 135-152cm, (single) (07290012127243)
Device Identifier (DI) Information
ThermoWrap™ Universal 135-152cm, (single)
500-03153
In Commercial Distribution
500-03153
BELMONT INSTRUMENT CORPORATION
500-03153
In Commercial Distribution
500-03153
BELMONT INSTRUMENT CORPORATION
Accessory for the Allon 2001 system. A body wrap connected to the thermoregulation system.
Device Characteristics
MR Unsafe | |
No | |
Yes | |
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).
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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 |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
806affd8-ca9c-4482-89ab-79350e4efbf1
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 |
---|---|---|---|---|---|
27290012127247 | 12 | 07290012127243 | In Commercial Distribution | Box | |
57290012127248 | 6 | 07290012127243 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined