Dolphin II Plus

Basic Information

• Brand Name: Dolphin II Plus
• Primary DI: 05903684806683
• Version / Model: 90564
• Catalog Number: 01-KPR-0108-001
• 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: 2023-10-18
• Public Version: 1
• Public Version Date: 2023-10-26
• Public Version Status: New
• Public Device Record Key: 5f1db23c-7a88-48ec-85c8-75c1301da905

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. The chair allows the operator to adjust both, height and tilt of the seat enabling the patient to remain in the fixed position for a long time. The device is intended for use in privet homes, hospitals, sanatoriums, nursing homes or any other care facilities. Patients can be moved only through horizontal flat surfaces, and one floor of the building. If you need to transport on flat inclined/tilted surfaces, an additional person is recommended to assist with patient care.

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	Medical Specialty	Regulation #	Device Class
FML	Chair, Blood Donor	General Hospital	880.6140	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	05903684806683	GS1