FDA UDI
In Commercial Distribution
🇺🇸 United States
Invisia™ BathBench ADA (Matte Black, Ash Stain)
DI: 00689281034517
·
Model: INV-WSBB-ADA-ASH-BLK
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Invisia™ BathBench ADA (Matte Black, Ash Stain)
- Primary DI
- 00689281034517
- Version / Model
- INV-WSBB-ADA-ASH-BLK
- Catalog Number
- 03451
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-30
- Public Version
- 1
- Public Version Date
- 2021-09-07
- Public Version Status
- New
- Public Device Record Key
- 31383333-5629-49fb-9860-51b5dc04ca6d
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281034517 | GS1 |