AccessGUDID - DEVICE: Zippie® Series Manual Wheelchair (05022408045938)

GUDID

Device Identifier (DI) Information

Brand Name: Zippie® Series Manual Wheelchair
Version or Model: ElZ1A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ElZ1A
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 05022408045938
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: Zippie TS Manual Wheelchair

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Wheelchair, occupant-driven, rear-wheels-operated, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device. The occupant moves the device by rotating both rear wheels. The device cannot be folded or readily dismantled for transport.

FDA Product Code

[?]

Product Code	Product Code Name
IOR	WHEELCHAIR, MECHANICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973673	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: 57fad125-e68c-45d2-9a21-3b02d754bb17
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 23, 2016