Home GUDID 07331791015083 Freevent® HME 15 Regular
Primary DI 07331791015083
Brand Freevent® HME 15 Regular
Company Atos Medical AB
Model 7742
Device description Freevent HME 15 is a Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a ISO 15 mm connector. The HME conditions inhaled air by retaining heat and moisture from the exhaled air. The device also partially restores lost breathing resistance.
Published 2020-05-29
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name JOH Tube Tracheostomy And Tube Cuff
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JOH Tube Tracheostomy And Tube Cuff Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07331791017841 Package GS1 30 In Commercial Distribution 07331791008207 Previous GS1 0 07331791015069 Primary GS1 0 07331791015083 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07331791017841 07331791017841 7331791017841 07331791008207 07331791008207 7331791008207 07331791015069 07331791015069 7331791015069 07331791015083 07331791015083 7331791015083
GMDN Terms# Term, Definition table Term Definition Tracheostomy tube speech valve A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 15 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 36 Degrees Fahrenheit 108 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep away from rain. Keep away from sunlight. Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight. Storage Environment Temperature 2 Degrees Celsius 42 Degrees Celsius Storage Environment Temperature 36 Degrees Fahrenheit 108 Degrees Fahrenheit
Regulatory Flags# DUNS number 355470923 Device count 30 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10887709200668 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200675 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200682 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200699 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200705 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200729 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200736 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200767 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709200781 Bivona ICU MEDICAL, INC. JOH 2026-08-07 10887709198385 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709198866 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709198880 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199368 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199580 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199641 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199764 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199771 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199788 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199801 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199818 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199825 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199832 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199849 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199856 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709199863 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709200002 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709200019 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709200026 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709200033 Bivona ICU MEDICAL, INC. JOH 2026-08-03 10887709200149 Bivona ICU MEDICAL, INC. JOH 2026-08-03
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