DEVICE: BRAEBON cTherm Cannula Thermistor (B14005140)
Device Identifier (DI) Information
BRAEBON cTherm Cannula Thermistor
0514
In Commercial Distribution
0514
Braebon Medical Corporation
0514
In Commercial Distribution
0514
Braebon Medical Corporation
Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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37340 | General-purpose patient temperature probe, reusable |
A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZQ | Monitor, Breathing Frequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K981445 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 5 and 32 Degrees Celsius |
Storage Environment Temperature: between 0 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
371eef7e-3be9-4d42-a7c3-31aabcbbda22
July 06, 2018
3
September 22, 2016
July 06, 2018
3
September 22, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6138316690
info@braebon.com
info@braebon.com