AccessGUDID - DEVICE: Invisia™ BathBench (Matte White, 35"/889mm, Honey Stain) (00689281033893)

GUDID

Device Identifier (DI) Information

Brand Name: Invisia™ BathBench (Matte White, 35"/889mm, Honey Stain)
Version or Model: INV-WSBB-35-HNY-WHT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03389
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281033893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).

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?
41051	Bath board	A device in the form of a flat board designed to be sat upon by an adult patient who is bathing in a bath (usually while being attended/assisted) to elevate the patient out of the water except for the feet. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device typically includes a solid or ribbed flat seat and is secured across the rim of the bath; it is typically made of water-resistant or waterproof materials. The device 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: 85921dc2-cf98-4f8c-85e6-01f11f929f15
Public Version Date: September 07, 2021
Public Version Number: 1
DI Record Publish Date: August 30, 2021