DEVICE: BRAEBON Disposable RIP Belt (B14055770)
Device Identifier (DI) Information
BRAEBON Disposable RIP Belt
5577
In Commercial Distribution
5577
Braebon Medical Corporation
5577
In Commercial Distribution
5577
Braebon Medical Corporation
Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
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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35244 | Pneumograph |
A device designed to graphically display chest movement during the respiratory cycle. It uses a sensor, e.g. Electrical impedance, to detect and transduce respiratory chest movement and may display both the rate and waveform of the movement.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BZQ | Monitor, Breathing Frequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K001743 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 115 Feet |
Device Record Status
2dc74147-0ebb-4058-a499-9547e89ea9b2
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