FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00857684007005
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
UDK_USBW
Device description
Personal CareAids to Daily Living Product Description: Uccello Kettle, RTL, 1/EA, 4/CS
Published
2019-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKWUTENSIL, HOMEMAKING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKWUtensil, HomemakingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50857684007000PackageGS14Not in Commercial Distribution
00857684007005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085768400700050857684007000
00857684007005008576840070058576840070050857684007005

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840252900617Sta-SteadyTherafin CorporationIKW2023-07-10
B144MPC9501Molded Products, Inc.MOLDED PRODUCTS, INC.IKW2023-06-06
B144MPC9503Molded Products, Inc.MOLDED PRODUCTS, INC.IKW2023-06-06
07320450002397Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320450002434Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320450002441Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320450002458Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320450002465Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320451357359Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320451357366Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
07320451357373Etac Supply Center ABEtac Supply Center ABIKW2022-12-07
50857684007000DRIVEMEDICALDrive Devilbiss HealthcareIKW2019-06-21