AccessGUDID - DEVICE: Hygiene Elite - Tollos (00817956022686)

GUDID

Device Identifier (DI) Information

Brand Name: Hygiene Elite - Tollos
Version or Model: T015HXXF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 1073849 Ontario Limited

Primary DI Number: 00817956022686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049181763 *Terms of Use

Device Description: Hygiene Elite Sling - XLarge - Blue Binding - 6 Loop - Tricot Material - Reuseable

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?
33476	Patient lifting system divided leg sling	A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their legs held apart and posterior exposed for toileting and washing. It is typically designed as a U-shaped sling construction made of strengthened fabric with lifting straps, a back support with or without head support and individual leg straps (bands) that are wrapped around each leg to support the patient/person in a sitting position with divided legs. This is a reusable device.	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
Height: 24 Inch
Width: 19 Inch
Depth: 3 Inch

Device Record Status

Public Device Record Key: 4b4f2788-67ad-4174-9389-2692b81a297f
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022