FDA.reportPublic FDA data

GuruNanda Portable Nasal Irrigator

Primary DI
00810051084849
Brand
GuruNanda Portable Nasal Irrigator
Company
Gurunanda, LLC
Model
4000
Published
2024-03-11
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
KMAIrrigator, Powered Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051084849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051084849008100510848498100510848490810051084849

GMDN Terms#

Term, Definition table
TermDefinition
Nasal lavage systemA device assembly designed for automated or semi-automated irrigation and washing of tissue and/or debris from the nose and/or the nasal sinuses. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the nostrils. The system is used mainly for allergy treatment, nasal congestion, and before and after surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079671169
Device count
1
Premarket exempt
true

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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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00767056181526HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
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