AccessGUDID - DEVICE: Quickie SR45 (00016958053661)

GUDID

Device Identifier (DI) Information

Brand Name: Quickie SR45
Version or Model: SR45
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIZ9
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 00016958053661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value.

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):	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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41619	Wheelchair, attendant-driven, 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 and steered by an attendant who pushes with both hands on the handles of the wheelchair. The device cannot be folded or readily dismantled for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K952641	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: a7531350-f8d3-44b0-99c1-c0fce3f679f2
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: May 04, 2021