AccessGUDID - DEVICE: Jerry (06934374100278)

GUDID

Device Identifier (DI) Information

Brand Name: Jerry
Version or Model: JRWD6012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.

Primary DI Number: 06934374100278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 549752487 *Terms of Use

Device Description: Electric Wheelchair (Model: JRWD6012)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
47965	Multi-terrain sports wheelchair, electric-motor-driven	A wheeled personal mobility device incorporating a seat-support system for a person with a walking disability that is propelled by power from one or more electric motor(s) for multi-/all-terrain sports use. The electronic control of speed and manual control of direction is performed by the occupant; the wheels may include caterpillar tracks. This device is designed for unlimited off-road sports use on sand, rocky terrain, grass, snow, and/or wet ground.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192739	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: 8b6745c5-22ae-469a-a868-f9cdfd408160
Public Version Date: November 01, 2021
Public Version Number: 1
DI Record Publish Date: October 22, 2021