DEVICE: BRAEBON Q-RIP Belt (B14005720)
Device Identifier (DI) Information
BRAEBON Q-RIP Belt
0572
In Commercial Distribution
0572
Braebon Medical Corporation
0572
In Commercial Distribution
0572
Braebon Medical Corporation
Belt for the Q-RIP™ Respiratory Effort System™ which is 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: 48 Inch |
Device Record Status
dc8dc6db-f9d4-4389-8207-13d536d5dd97
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