AccessGUDID - DEVICE: Folding Shower Seat (00689281035262)

GUDID

Device Identifier (DI) Information

Brand Name: Folding Shower Seat
Version or Model: FDS-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03526
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281035262
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Fold Down Seat is a high quality, commercial grade, fold down shower seat. The Fold Down Seat is intended to provide shower seating support for people with reduced mobility. The Fold Down Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Fold Down Seat is intended to be folded up when not in use. The hinge allows the seat to open slowly, and lock against the wall in the folded position. The Fold Down Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 440lbs / 200kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Fold Down Seat is not to be used in any other way than described above.

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?
34936	Shower seat, non-powered	A non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	Aid, Transfer

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: e777ab69-f6ad-4b66-b491-7b61b1bf1210
Public Version Date: February 08, 2022
Public Version Number: 1
DI Record Publish Date: January 31, 2022