Identity
- Trade Name
- Dolphin II FDA UDI
- Generic Name
- Commode, electrically-powered FDA UDI
- Device Name
- The mobile Dolphin II Commode/shower chair is to be used exclusively for assistance during moving or performing daily routine activities of persons with physical impairment disabilities. FDA UDI
- Model / Reference
- 90561 FDA UDI
- Description
- The mobile Dolphin II Commode/shower chair is to be used exclusively for assistance during moving or performing daily routine activities of persons with physical impairment disabilities. FDA UDI
Identifiers
- Catalog Number
- 01-KPR-0105-001 FDA UDI
- Primary DI / UDI-DI
- 05903684806867 FDA UDI
- FDA Product Code
- FSA FDA UDIILS FDA UDI
- GMDN Term
- Commode, electrically-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5510 FDA UDI890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Commode, electrically-powered
Dolphin II by Meden Inmed Sp Z O O — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meden Inmed Sp Z O O
Sources (1)
- FDA UDI adb48c32-1bef-4b6b-902b-81ad2043dd24 34 fields · synced May 30, 2026