FDA UDI
In Commercial Distribution
🇺🇸 United States
Invisia™ Shower Bench, 24"/610mm (Matte Grey, Ash Stain)
DI: 00689281033770
·
Model: INV-WSSB-24-ASH-PCG
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Invisia™ Shower Bench, 24"/610mm (Matte Grey, Ash Stain)
- Primary DI
- 00689281033770
- Version / Model
- INV-WSSB-24-ASH-PCG
- Catalog Number
- 03377
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-31
- Public Version
- 1
- Public Version Date
- 2021-09-08
- Public Version Status
- New
- Public Device Record Key
- 5d87f869-a3ce-4134-808a-71f940eba11b
Device Description
The Invisia Shower Bench is a high quality, commercial grade shower seat. The Invisia Shower Bench is intended to provide shower seating support for people with reduced mobility. 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 bench).
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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281033770 | GS1 |