AccessGUDID - DEVICE: WHEELCHAIR TIRE (00606509900232)

GUDID

Device Identifier (DI) Information

Brand Name: WHEELCHAIR TIRE
Version or Model: WHEELCHAIR TIRE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: Pride Mobility Products Corp

Primary DI Number: 00606509900232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: A circular cushion of rubber and/or synthetic material which is fitted to a wheelchair wheel rim and which functions as a soft contact to the surfaces upon which the wheelchair stands and provides the wheelchair with traction and some shock absorption as it is propelled. It comes in a variety of designs, diameters and sizes. This is appropriate for spare and replacement tires.

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:	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?
36232	Wheelchair tyre	A circular cushion of rubber and/or synthetic material which is fitted to a wheelchair wheel rim and which functions as a soft contact to the surfaces upon which the wheelchair stands and provides the wheelchair with traction and some shock absorption as it is propelled. It comes in a variety of designs, diameters and sizes. This GMDN code is appropriate for spare and replacement tyres (tires).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, 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: 6543608a-db5b-448a-babe-519c4c7d9457
Public Version Date: March 03, 2023
Public Version Number: 2
DI Record Publish Date: August 26, 2019