FDA UDI In Commercial Distribution 🇺🇸 United States

Dolphin II

DI: 05903684806867 · Model: 90561 · MEDEN INMED SP Z O O
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dolphin II
Primary DI
05903684806867
Version / Model
90561
Catalog Number
01-KPR-0105-001
Company Name
MEDEN INMED SP Z O O
Labeler DUNS
367142903
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-20
Public Version
1
Public Version Date
2025-08-28
Public Version Status
New
Public Device Record Key
adb48c32-1bef-4b6b-902b-81ad2043dd24

Device 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.

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FSA Lift, Patient, Non-Ac-Powered
ILS Adaptor, Hygiene

GMDN Terms

Code Name
66671 Commode, electrically-powered

Identifiers

Type ID
Primary 05903684806867