FDA UDI
In Commercial Distribution
🇺🇸 United States
PLUS
DI: 05708590376844
·
Model: R7864
·
Pressalit A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PLUS
- Primary DI
- 05708590376844
- Version / Model
- R7864
- Catalog Number
- R7864000
- Company Name
- Pressalit A/S
- Labeler DUNS
- 305656662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 1
- Public Version Date
- 2021-06-22
- Public Version Status
- New
- Public Device Record Key
- a7d08f06-10ba-4ea0-8739-58bc5276a6f6
Device Description
PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, white. Electrically height adjustable, manually sideways adjustable, for fitting to horizontal wall track
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63008 | Shower seat, power-adjusted | An electrically-powered device designed to be sat upon by a patient (adult or child) while washing in a bath, shower, or other washing facility. The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device is typically in the form of a fixed seat (e.g., wall-mounted) with powered controls to adjust position (typically height), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof 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 | 05708590376844 | GS1 |
Customer Contacts
- Phone
- +4587888788
- [email protected]