AccessGUDID - DEVICE: PLUS (05708590374444)

GUDID

Device Identifier (DI) Information

Brand Name: PLUS
Version or Model: R7864
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R7864112
Company Name: Pressalit A/S

Primary DI Number: 05708590374444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, anthracite gray. Electrically height adjustable, manually sideways adjustable, for fitting to horizontal wall track

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?
63008	Shower seat, power-adjusted	An electrically-powered device designed to be sat upon by a patient (adult or child) while washing in a bath, shower, or other washing facility. The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device is typically in the form of a fixed seat (e.g., wall-mounted) with powered controls to adjust position (typically height), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials. It may be used in a hospital, institution, or home.	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: b81e18a7-71de-4b78-8016-7cd1689297b3
Public Version Date: June 22, 2021
Public Version Number: 1
DI Record Publish Date: June 14, 2021