AccessGUDID - DEVICE: BRAEBON Communication Cable for MediByte (B1408889210)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON Communication Cable for MediByte
Version or Model: 8889.21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8889.21
Company Name: Braebon Medical Corporation

Primary DI Number: B1408889210
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Cable for connecting the MediByte to the computer for configuration and data download.

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

GMDN Preferred Term Name	GMDN Definition
Medical device USB cable	An insulated metal wire(s) intended to be used to standardize the connection between an electronic medical device and a computer for communication and/or power supply.

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061764	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 Temperature: between 0 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 146b6121-1b70-49d5-ac93-9b1ed046184d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016