FDA.reportPublic FDA data

WaterPik Ultra Plus and Cordless Express Water Flosser Combo

Primary DI
00073950343589
Brand
WaterPik Ultra Plus and Cordless Express Water Flosser Combo
Company
WATER PIK, INC.
Model
20034358
Catalog number
WF-150W/WF-02W010
Device description
Countertop Water Flosser White, Handheld Water Flosser White
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00073950343589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073950343589000739503435890739503435890073950343589

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

Contacts#

Phone, Email table
PhoneEmail
1-800-525-2774serivce@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073950341295Waterpik Cordless Pearl Water Flosser20034561WF-31CD0102026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water Flosser20034592WF-34W012(S)2026-06-09
00073950346788Waterpik Cordless Pulse 3100 Water Flosser20034678WF-20CD0152026-05-26
00073950345897Waterpik Cordless Enhance 3200 Water Flosser20034589WF-34W010(S)2026-05-26
00073950346122Waterpik Cordless Water Flosser20034612WF-35W017(S)2026-05-26
00073950347167Waterpik Cordless 1200 Water Flosser20034616WF-36W011(S)2026-05-26
10056310971209Water Pik Revive with PowerPulse20034197-120CURV-563M2025-04-09
00073950337885WaterPik Transform RV with PowerPulsePHR-553EPHR-553E2025-01-29
00073950337960WaterPik Transform RV with PowerPulsePHR-559EPHR-559E2025-01-29
00073950338011WaterPik Transform RV with PowerPulsePHR-551EPHR-551E2025-01-29
00073950339230WaterPik Caddy Buddy with PowerPulsePHO-553MEPHO-553ME2025-01-29
00073950339322WaterPik Caddy Buddy with PowerPulsePHO-559MEPHO-559ME2025-01-29
00073950339346WaterPik Caddy Buddy with PowerPulsePHO-555EPHO-555E2025-01-29
00073950333689Waterpik PowerPulse with DualDockQMR-863MEQMR-863ME2024-04-29
00073950333726Waterpik PowerPulse with DualDockQMR-869MEQMR-869ME2024-04-29
00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
00073950334303Waterpik PowerPulseXSP-755MEXSP-755ME2024-04-29
00073950333184Waterpik PowerPulseXFT-763MEXFT-763ME2024-04-02
00073950332996Waterpik RainFall+ with PowerPulse XED-633EXED-633E2024-03-15
00073950333122Waterpik PowerPulseYCN-635EYCN-635E2024-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950341295Waterpik Cordless Pearl Water FlosserWATER PIK, INC.EFS2026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-06-09
05060640673700OrdoORDOCLUB LTDEFS2026-05-29
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