AccessGUDID - DEVICE: U-Sling with Head Support

GUDID

Device Identifier (DI) Information

Brand Name: U-Sling with Head Support - Large
Version or Model: 10745LG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117300286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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):	No
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?
40535	Solid-seat mobile patient lifting system seat	A lifting device used together with a solid-seat mobile lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position for transfer and (re)positioning. It is designed as a seat with a solid surface (this may be padded) upon which the person to be lifted is sat and contained during the lifting process.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-Powered

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: f6574cc6-dd79-4437-b859-8f22fdd421da
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: December 30, 2019