AccessGUDID - DEVICE: NA (00842307101093)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 6722-18-61-78-29-04-07-5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GENDRON, INC.

Primary DI Number: 00842307101093
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 054164587 *Terms of Use

Device Description: WHEELCHAIR,22X18DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

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?
41328	Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible	A wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: 1bcb4326-57b6-47c6-8ad0-0f0fbeb79876
Public Version Date: November 16, 2021
Public Version Number: 3
DI Record Publish Date: November 11, 2016