AccessGUDID - DEVICE: Assembly Required Distributors O+Inc. (00860004575610)

GUDID

Device Identifier (DI) Information

Brand Name: Assembly Required Distributors O+Inc.
Version or Model: WCM2025NF50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Assembly Required Distributors Inc

Primary DI Number: 00860004575610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170562396 *Terms of Use

Device Description: Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity, less front rigging, Green

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
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?
57980	Bariatric transport wheelchair, collapsible	A wheeled personal mobility device designed for transporting bariatric (obese) persons over short distances and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a heavy-duty framework and extra wide seat-support system for an obese person with a disability or obese person without the full capacity to walk. It also includes footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973418	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: 2367e904-7d6d-45bb-865b-af18723639bf
Public Version Date: October 04, 2023
Public Version Number: 2
DI Record Publish Date: April 11, 2022