AccessGUDID - DEVICE: Merits (00835246004662)

GUDID

Device Identifier (DI) Information

Brand Name: Merits
Version or Model: P331 30200719
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P331 30200719
Company Name: Merits Health Products, Inc.

Primary DI Number: 00835246004662
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879307148 *Terms of Use

Device Description: Ultra Hd, Power Base P331

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):	Yes
Kit:	No
Combination Product:	Yes
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?
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113577	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1a899b4-aa13-471d-aab7-a72d467acc8d
Public Version Date: October 09, 2024
Public Version Number: 1
DI Record Publish Date: October 01, 2024