AccessGUDID - DEVICE: BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 4 (B1400528A40)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 4
Version or Model: 0528A4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0528A4
Company Name: Braebon Medical Corporation

Primary DI Number: B1400528A40
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, Breathing Frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982216	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
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
No Device Sizes

Device Record Status

Public Device Record Key: 9215b3ee-736f-432a-8747-5b7bb1ec595e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016