AccessGUDID - DEVICE: CAREX HEALTH BRANDS (00627394121014)

GUDID

Device Identifier (DI) Information

Brand Name: CAREX HEALTH BRANDS
Version or Model: CCFPS3017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00627394121014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: UPLIFT PREMIUM POWER LIFTING SEAT, 17"

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?
17976	Lifting seat cushion	An electrically-powered cushioned device designed to be placed on a chair or other surface for sitting, and to help lift its occupant to stand from the sitting position; it is typically used by elderly or disabled patients who have difficulty rising from a seated position. It may be in the form of a portable, two-piece, hinged structure with a mechanism that lifts the seating surface mechanically (e.g., by springs), or in the form of an inflatable cushion with an integrated pump. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INN	Chair, Adjustable, Mechanical

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: e763817f-d50a-462d-9328-6fd65ce094fe
Public Version Date: September 06, 2023
Public Version Number: 2
DI Record Publish Date: September 07, 2020