FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
50857684007000
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
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
Melting pot unitA mains electricity (AC-powered) device designed for the melting and pouring/tapping of materials in a safe and controlled manner, e.g., paraffin wax for use in the laboratory for embedding tissue samples, Rose's metal for the production of beam blocks in radiotherapy departments. It consists of a heating element that can be of varying designs, e.g., hollow thermal heater, flat plate heater, and a pot/pitcher that may pour through an open top or have a tap at the bottom for the tapping of clean material avoiding residue that may have risen to the surface.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00857684007005DRIVEMEDICALDrive Devilbiss HealthcareIKW2019-06-21