FDA.reportPublic FDA data

CareOne

Primary DI
00041520137852
Brand
CareOne
Company
Ahold U.S.A., Inc.
Model
SUK
Device description
Oral Care Kit
Published
2020-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEQToothbrush, Powered
JESFloss, Dental
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1
JESFloss, DentalDental1
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041520137859PackageGS124In Commercial Distribution
00041520137852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152013785910041520137859
00041520137852000415201378520415201378520041520137852

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.

Regulatory Flags#

DUNS number
170199058
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041520078438CareOne0415200784382019-08-30
00041520010704CareOne0415200107042019-06-28
00041520013965CareOne0415200139652020-09-27
00041520014009CareOne0415200140092019-06-28
00041520019714CareOne0415200197142019-06-28
00041520089298CareOne0415200892982019-07-31
00041520089304CareOne0415200893042019-06-28
00041520096777CareOne0415200967772019-07-31
00041520096784CareOne0415200967842019-07-31
00041520096791CareOne0415200967912019-06-28
00041520096821CareOne0415200968212019-06-28
00041520125033CareOne0415201250332019-07-31
00041520875754CareOne0415208757542019-06-28
00041520877710CareOne0415208777102019-06-28
00041520877727CareOne0415208777272019-06-28
00041520880963CareOne0415208809632019-06-28
00341520317170CareOne3415203171702020-09-27
00341520877889CareOne3415208778892019-07-31
00041520171283Care OneDigital Pregnancy Test2021-04-22
00041520171269Care OneOne Step Pregnancy Test2021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931718193910nature FreshNew Phenix Home Products Manufactory Co., Ltd.JES2026-10-15
06938320799899SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799905SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799912SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799929SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799936SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799943SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799950SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799967SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799981SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799998SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
00070942007160GUM®SUNSTAR AMERICAS, INC.JES2026-10-08
05060640673731OrdoORDOCLUB LTDJEQ2026-09-22
05060640673748OrdoORDOCLUB LTDJEQ2026-09-22
05060640674097OrdoORDOCLUB LTDJEQ2026-09-22
05060640674141OrdoORDOCLUB LTDJEQ2026-09-22
05060640674486OrdoORDOCLUB LTDJEQ2026-09-22
00818746020042Gingi-Plain Max Soft-TwistGingi PakJES2026-08-26
00818746020073Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020080Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020097Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020103Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
08800017900155DX-Ultra Ultrasonic IrrigationDXM CO., LTDJET2026-08-21
08800017902500DX-Ultra Ultrasonic IrrigationDXM CO., LTDJET2026-08-21
00840456224762JMUJMU DENTAL, INCJES2026-08-18
00070942008334GUM®SUNSTAR AMERICAS, INC.JES2026-07-28
00840456214701JMUJMU DENTAL, INCJES2026-07-24
00840456214718JMUJMU DENTAL, INCJES2026-07-24
06931718175657HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175664HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23