FDA.report

CONAIR

Primary DI
00085452000730
Brand
CONAIR
Company
CONAIR CORPORATION
Model
SWJ2
Device description
Oral Irrigator
Published
2022-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EFSUnit, Oral Irrigation

Product Code Classifications

CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00085452000730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00085452000730000854520007300854520007300085452000730

GMDN Terms

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

Regulatory Flags

DUNS number
001661222
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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00074108356581CONAIRWW3462024-01-15
00074108452917CONAIRHP01XG2024-01-05
00074108451200CONAIRWW714ZF2023-07-17
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00074108454584ConairITH902023-07-17
00074108458995CONAIRWW934ZF2023-07-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
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
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
00073950343589WaterPik Ultra Plus and Cordless Express Water Flosser ComboWATER PIK, INC.EFS2026-01-08
00073950038232WaterPik Cordless Select 5100 Water FlosserWATER PIK, INC.EFS2026-01-05
00073950342360WaterPik Cordless Plus 5000 Water Flosser (2PK)WATER PIK, INC.EFS2026-01-05
00073950342438WaterPik Cordless Advanced 2.0 Water Flosser (6PK)WATER PIK, INC.EFS2026-01-05
00073950342773WaterPik Cordless 1100 Water Flosser (6 PK)WATER PIK, INC.EFS2026-01-05
00073950000185WaterPik Promax WaterflosserWATER PIK, INC.EFS2025-12-09
10073950337240WaterPik Promax Waterflosser 6PKWATER PIK, INC.EFS2025-12-09
06976344070150ABOBOMiley Technology (Hebei) Co., LTDEFS2025-11-20
00817277020934UsmileGuangzhou Stars Pulse Co., Ltd.EFS2025-11-17
00817277021085UsmileGuangzhou Stars Pulse Co., Ltd.EFS2025-11-17
00860014476112SmileSet Premium Handheld Water Flosser – BlackOrtho Dental Lab LLCEFS2025-09-25
00860014476129SmileSet Premium Handheld Water Flosser – MintOrtho Dental Lab LLCEFS2025-09-25
00850078989000SmileSet WF500 Water Flosser – WhiteOrtho Dental Lab LLCEFS2025-09-17
00850078989024SmileSet Water Flosser Replacement Tips - 4 packOrtho Dental Lab LLCEFS2025-09-17
06926347961061eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10
06926347961078eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10
06926347968916eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10
06926347968923eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10
00073950335232Water Pik Ultra Plus WaterflosserWATER PIK, INC.EFS2025-07-02