FDA.reportPublic FDA data

Philips Sonicare

Primary DI
00075020091260
Brand
Philips Sonicare
Company
PHILIPS ORAL HEALTHCARE, LLC
Model
HX3704/20
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EFSUNIT, ORAL IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020091260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020091260000750200912600750200912600075020091260

GMDN Terms#

Term, Definition table
TermDefinition
Water jet flosser/sonic electric toothbrushAn electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece, and to provide (sonic) vibration for toothbrush heads attached to the handpiece for brushing the teeth. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608729869
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075020072009Philips SonicareHX6062/902022-11-30
00075020072023Philips SonicareHX6062/922022-11-30
00075020072207Philips SonicareHX9023/922022-11-30
00075020106513Philips One BH1022/202022-10-12
00075020106544Philips OneHY1100/062022-10-12
00075020105691Philips SonicareHX9994/122022-09-01
00075020105011Philips SonicareHX3601/012022-08-16
00075020105028Philips SonicareHX9911/902022-06-28
00075020105035Philips SonicareHX9911/912022-06-28
00075020105042Philips SonicareHX9911/922022-06-28
00075020105059Philips SonicareHX9911/932022-06-28
00075020103857Philips oneHY1100/532022-05-20
00075020103864Philips OneHY1100/542022-05-20
00075020103475Philips SonicareHX6829/312022-04-08
00075020104038Philips SonicareHX6829/752022-04-08
00075020104700Philips SonicareHX9068/802022-04-08
00075020104717Philips SonicareHX9068/812022-04-08
00075020095664Philips SonicareHX9048/822022-04-07
00075020103772Philips SonicareHX6068/402022-04-07
00075020095657Philips SonicareHX6068/822022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00100739503381Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00056310343870Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
00056310343900Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
10073950278192Water Pik Ultra Waterflosser (3pk)WATER PIK, INC.EFS2026-01-12