DEVICE: BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 (B1400528A0)

Device Identifier (DI) Information

BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3
0528A
In Commercial Distribution
0528A
Braebon Medical Corporation
B1400528A0
HIBCC

1
251731105 *Terms of Use
PVDF Respiratory effort sensor is intended for use during sleep disorder studies as a qualitative measure of respiratory effort for recording onto a data acquisition system. The sensor uses PVDF (piezo-electric) technology and plugs directly into the electrode headbox.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
BZQ Monitor, Breathing Frequency
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8489be3b-efaf-4753-9ff3-2b0744d8f168
March 29, 2018
2
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
613.831.6690
info@braebon.com
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