FDA.reportPublic FDA data

Dolphin II

Primary DI
05903684806867
Brand
Dolphin II
Company
MEDEN INMED SP Z O O
Model
90561
Catalog number
01-KPR-0105-001
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.
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903684806867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903684806867059036848068675903684806867

GMDN Terms#

Term, Definition table
TermDefinition
Commode, electrically-poweredAn electrically-powered transportable device in the form of chair with a motorized height-adjustable seat and receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate wheels (castors).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367142903
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903684801671MONTANE ATLAS M-S3.F4 [SZER 69 CM]01-STO-3007-00135362022-11-04
05903684802074MONTANE ALPS M-P5.F4 [SZER 69 CM]01-STO-3023-00133582022-11-04
05903684801428MONTANE TATRAS M-S2.F0 [SZER 69 CM]01-STO-3002-00435202022-11-03
05903684801459MONTANE TATRAS M-S2.F4 [SZER 69 CM]01-STO-3003-00135232022-11-03
05903684801619MONTANE ATLAS M-S3.F0 [SZER. 69 CM]01-STO-3006-00135352022-11-03
05903684801251GALAXY TRACTION T3.F0 [SZER 70 CM] XL01-STO-3407-00532632023-11-15
05903684801299GALAXY TRACTION T3.F4 XL [SZER 70 CM]01-STO-3408-00532642023-11-15
05903684801381GALAXY TRACTION T4.F4 XL [SZER 70 CM] 01-STO-3424-00532672023-11-15
05903684803248TRITON 6 E (SZER. 69) 01-STO-3620-0024769E2023-11-06
05903684802319MONTANE ANDES M-P7.F4 [SZER 76 CM]01-STO-3025-0053573XL2023-09-25
05903684802142TRITON 6 E (SZER. 70) 01-STO-3620-0014769E2022-11-07
05903684803231TRITON 6 M (SZER. 70) 01-STO-3610-0024769M2022-11-07
05903684800315MONTANE TATRAS GERLACH E-S2.F4 [SZER. 69 CM]01-STO-3031-00135252022-11-04
05903684801756MONTANE ATLAS M-P3.F0 [SZER 69 CM]01-STO-3020-00435372022-11-04
05903684801787MONTANE ATLAS M-P3.F0 [SZER 69 CM] US01-STO-3020-00435322022-11-04
05903684801817MONTANE ATLAS M-P3.F4 [SZER 69 CM]01-STO-3021-001313622022-11-04
05903684801848MONTANE ATLAS M-P3.F4 [SZER 69 CM] US01-STO-3021-00435332022-11-04
05903684801879MONTANE ALPS M-S5.F0 [SZER. 69] 01-STO-3008-00135552022-11-04
05903684801909MONTANE ALPS M-S5.F0 [SZER. 69 CM] US01-STO-3008-00435502022-11-04
05903684801930MONTANE ALPS M-S5.F4 [SZER 69 CM] 01-STO-3009-00135562022-11-04

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