FDA UDI
In Commercial Distribution
🇺🇸 United States
SHOWER STOOL
DI: 00689281033848
·
Model: SST-S
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SHOWER STOOL
- Primary DI
- 00689281033848
- Version / Model
- SST-S
- Catalog Number
- 03384
- 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
- 9f0c4b3c-854d-4d18-a35c-4645d9b6445b
Device Description
The Shower Stool is a high quality, commercial grade shower seat. The Shower Stool is intended to provide seating support for people with reduced mobility. The maximum user weight for this product is 300lbs / 136kgs. 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
- No
- 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 | 00689281033848 | GS1 | ||||
| Package | 10689281033845 | GS1 | CARTON | 4 | In Commercial Distribution |