DEVICE: BRAEBON Ultima Pressure Sensor (B14005810)
Device Identifier (DI) Information
BRAEBON Ultima Pressure Sensor
0581
In Commercial Distribution
0581
Braebon Medical Corporation
0581
In Commercial Distribution
0581
Braebon Medical Corporation
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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31278 | Air/gas pressure transducer |
A noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing).
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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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K984431 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8b9d1729-e495-4726-884b-f069f8e8a413
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
613.831.6690
info@braebon.com
info@braebon.com