FDA.reportPublic FDA data

GuruNanda Portable Water Flosser R3100

Primary DI
00810051085839
Brand
GuruNanda Portable Water Flosser R3100
Company
Gurunanda, LLC
Model
R3100
Published
2024-02-13
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
00810051085839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051085839008100510858398100510858390810051085839

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.

Regulatory Flags#

DUNS number
079671169
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00810051089004GuruNandaGNF1352026-01-28
00810051089479GuruNandaGNF1352026-01-28
00810051089530GuruNanda Ultrasonic Aligner Cleaning PodGN089532025-08-29
00810051088458GuruNanda Water Flosser H3200A H3200A2025-06-27
00810051081787GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
00810051083415GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGNF022025-05-06
00810051086515GuruNanda Water Flosser R3100AR3100A 4.02025-04-02
00810051086843GuruNanda Kids Water FlosserRK1002025-04-02
00810051087048GuruNanda Compact Water Flosser, HM100HM1002025-04-02
00810051087055GuruNanda Compact Water Flosser,HM1002025-04-02
00810051087109GuruNanda Professional Whitening Wireless Kit1.02025-04-01
00810051086317GuruNanda Compact Water Flosser HM100HM1002025-02-26
00810051084702GuruNanda Steel Sonic TB - Rose Gold5500A2024-03-13
00810051084719GuruNanda Steel Sonic TB - Gold5500A2024-03-13
00810051084726GuruNanda Steel Sonic TB - Teal5500A2024-03-13
00810051084764GuruNanda Rotary Toothbrush - Lavederi20002024-03-13

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Primary DI, Brand, Company table
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