FDA.reportPublic FDA data

Blue Water Flosser

Primary DI
00810131041304
Brand
Blue Water Flosser
Company
Supermouth LLC
Model
12000024
Device description
Water Irrigator bluecolor
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810131041304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131041304008101310413048101310413040810131041304

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049384038
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131045319Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Pearly White 40000222025-12-02
00810131045326Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Saphire Blue40000232025-12-02
00810131045333Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Rose Gold40000242025-12-02
00810131044190Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush40000172025-06-30
00810131044725Adult SuperScraper Silver100000072025-06-30
00810131044732Adult SuperScraper Rose Gold100000082025-06-30
00850036799993Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set 120000262025-06-30
00810131041502Adult Resuable Tongue Scraper 100000032025-05-25
00810131041519Ortho Resuable Tongue Scraper Silver100000042025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose Gold100000052025-05-25
00810131040000Super Vanilla Ortho Floss Fluoride07002020562024-06-01
00810131040017Super StrawberryOrtho Floss Fluoride07002040562024-06-01
00810131040024Super Mint Ortho Floss Fluoride07002050562024-06-01
00810131040031Super Chocolate Ortho Floss Fluoride07002030562024-06-01
00810131040215Superbrush Bluetooth Brush Junior040000012024-06-01
00810131040222Superbrush Orange A Peel Brush Junior040000022024-06-01
00810131040239Superbrush Yellow Sunshine Brush Junior040000032024-06-01
00810131040246Superbrush Tangerine Clean Toothbrush040000042024-06-01
00810131040253Superbrush Breath Mint Toothbrush040000052024-06-01
00810131040260Superbrush Blue Biome Toothbrush040000062024-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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