AccessGUDID - DEVICE: Assembly Required Distributors (00854362008361)

GUDID

Device Identifier (DI) Information

Brand Name: Assembly Required Distributors
Version or Model: WCM2424LS50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Assembly Required Distributors Inc

Primary DI Number: 00854362008361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170562396 *Terms of Use

Device Description: Stainless steel W/C, 24" width, 350 lb. cap. Rem. desk length arm, green, w/ seat belt, no front rigging

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":	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
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: 65ee3cb9-7961-4137-8eee-839fbde93b15
Public Version Date: October 04, 2023
Public Version Number: 3
DI Record Publish Date: April 23, 2018