AccessGUDID - DEVICE: WHEELCHAIR HAND WARMER (00606509900164)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00606509900164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: A small electrically-powered convection heater intended to be mounted on the armrest or tray of a wheelchair to warm the air around the hands of the wheelchair occupant. It may be powered by a connection to a powered wheelchair and may be supplied with a cover-like device intended to be placed around the hands to restrict the area of air to be heated.

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?
63573	Wheelchair hand warmer	A small electrically-powered convection heater intended to be mounted on the armrest or tray of a wheelchair to warm the air around the hands of the wheelchair occupant. It may be powered by a connection to a powered wheelchair and may be supplied with a cover-like device intended to be placed around the hands to restrict the area of air to be heated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNO	Accessories, 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: 25afc921-d86a-41d0-9776-a227178ce9b1
Public Version Date: March 03, 2023
Public Version Number: 2
DI Record Publish Date: August 26, 2019