AccessGUDID - DEVICE: BRAEBON Ultima Body Position Sensor (B1400530M0)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON Ultima Body Position Sensor
Version or Model: 0530M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0530M
Company Name: Braebon Medical Corporation

Primary DI Number: B1400530M0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Five-position sensor to accurately record body position during sleep studies.

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?
43267	Patient positioning sensor	A device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEL	Device, Sleep Assessment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981969	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: 8bdb9694-21a8-4dea-80ef-8cb9df3cfb2c
Public Version Date: July 15, 2024
Public Version Number: 4
DI Record Publish Date: September 22, 2016