Dolphin II Plus 01-KPR-0108-001

GUDID 05903684806683

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.

MEDEN INMED SP Z O O

Shower seat, non-powered
Primary Device ID05903684806683
NIH Device Record Key5f1db23c-7a88-48ec-85c8-75c1301da905
Commercial Distribution StatusIn Commercial Distribution
Brand NameDolphin II Plus
Version Model Number90564
Catalog Number01-KPR-0108-001
Company DUNS367142903
Company NameMEDEN INMED SP Z O O
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105903684806683 [Primary]

FDA Product Code

FMLChair, Blood Donor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-26
Device Publish Date2023-10-18

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