Home GUDID 07331791015090 Freevent® HME 22 Regular
Primary DI 07331791015090
Brand Freevent® HME 22 Regular
Company Atos Medical AB
Model 7747
Device description Freevent HME 22 Regular is a Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a Ø22mm 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 07331791017858 Package GS1 50 In Commercial Distribution 07331791008245 Previous GS1 0 07331791015076 Primary GS1 0 07331791015090 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 07331791017858 07331791017858 7331791017858 07331791008245 07331791008245 7331791008245 07331791015076 07331791015076 7331791015076 07331791015090 07331791015090 7331791015090
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 22 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 10887709196923 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709196954 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709197258 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709197388 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198149 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198637 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198644 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198651 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198668 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198675 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198682 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198699 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198705 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198712 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198729 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198736 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198743 Bivona ICU MEDICAL, INC. JOH 2026-07-17 10887709198415 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198422 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198439 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198446 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198453 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198460 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198477 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198484 Bivona ICU MEDICAL, INC. JOH 2026-07-16 10887709198163 Bivona ICU MEDICAL, INC. JOH 2026-07-14 10887709198170 Bivona ICU MEDICAL, INC. JOH 2026-07-14 10887709198187 Bivona ICU MEDICAL, INC. JOH 2026-07-14 10887709198194 Bivona ICU MEDICAL, INC. JOH 2026-07-14 10887709198200 Bivona ICU MEDICAL, INC. JOH 2026-07-14
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