Home GUDID 18018294018006 AirFeel IMT
Primary DI 18018294018006
Brand AirFeel IMT
Company FLAEM NUOVA SPA
Model P0124EM
Catalog number ACO822P
Device description Inspiratory muscles trainer
Published 2026-02-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ION Exerciser, Non-Measuring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ION Exerciser, Non-Measuring Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18018294018006 Package GS1 28 In Commercial Distribution 08018294018009 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18018294018006 18018294018006 08018294018009 08018294018009 8018294018009
GMDN Terms# Term, Definition table Term Definition Incentive spirometer A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 69 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 69 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -25 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 431208297 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08018294018009 AirFeel IMT P0124EM ACO822P 2026-02-18 08018294012793 FLAEM Rhino Clear Sprint P0709EM DR12P00 2020-07-10
Other Devices Sharing Product Codes# 
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