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 10887709195131 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195148 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195155 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195162 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195179 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195186 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195193 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195209 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195216 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195223 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195230 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195247 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195254 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195261 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195278 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709194967 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194974 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194981 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194998 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195001 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195018 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195025 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195032 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195049 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195056 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195063 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195070 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195087 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195094 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195100 Bivona ICU MEDICAL, INC. JOH 2026-06-05
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