Home GUDID 08018294012793 FLAEM Rhino Clear Sprint
Primary DI 08018294012793
Brand FLAEM Rhino Clear Sprint
Company FLAEM NUOVA SPA
Model P0709EM
Catalog number DR12P00
Device description Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose
Published 2020-07-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true Product Codes# Code, Name table Code Name JPW Pump, Nebulizer, Electrically Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JPW Pump, Nebulizer, Electrically Powered Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08018294012793 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08018294012793 08018294012793 8018294012793
GMDN Terms# Term, Definition table Term Definition Nasal irrigation set, home-use A collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 69 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 69 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 431208297 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 DI Brand Model Catalog Published 08018294018009 AirFeel IMT P0124EM ACO822P 2026-02-18 18018294018006 AirFeel IMT P0124EM ACO822P 2026-02-18
Other Devices Sharing Product Codes# 
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