AccessGUDID - DEVICE: Everest & Jennings (M3689P123011J1)

GUDID

Device Identifier (DI) Information

Brand Name: Everest & Jennings
Version or Model: 9P123011J
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9P123011J
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M3689P123011J1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: Rehab Shower Commode Chair Wheel Lock Pair

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):	No
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?
31158	Wheelchair brakes	A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This GMDN code also includes the necessary installation package.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INB	Attachment, Commode, Wheelchair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ebeaa42-cc75-4700-9ade-677bc23e83f0
Public Version Date: December 17, 2020
Public Version Number: 1
DI Record Publish Date: December 09, 2020