AccessGUDID - DEVICE: BRAEBON RIP Belt for MediByte, Pediatric (B1408572PED0)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON RIP Belt for MediByte, Pediatric
Version or Model: 8572PED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8572PED
Company Name: Braebon Medical Corporation

Primary DI Number: B1408572PED0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.

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 [?]
K001743	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
Length: 24 Inch

Device Record Status

Public Device Record Key: acc7194a-a0bb-460e-8e6c-d3f6d0521a9d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 17, 2017