Invisia™ SerenaSeat™ Standard 03539

GUDID 00689281035392

The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-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 Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.

Healthcraft Products Inc.

Shower seat, non-powered

• Primary Device ID: 00689281035392
• NIH Device Record Key: 1068082f-de33-43d7-a2ee-5c36262a64c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisia™ SerenaSeat™ Standard
• Version Model Number: INV-WSAL-18-WNT-PCG
• Catalog Number: 03539
• Company DUNS: 252468293
• Company Name: Healthcraft Products Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00689281035392 [Primary]

FDA Product Code

• IKX: Aid, Transfer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-09
• Device Publish Date: 2022-02-01

On-Brand Devices [Invisia™ SerenaSeat™ Standard]

• 00689281035446: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i
• 00689281035439: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i
• 00689281035422: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i
• 00689281035415: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i
• 00689281035408: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i
• 00689281035392: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is i