Home GUDID 00810050855815
ThermoFlo®
Primary DI 00810050855815
Brand ThermoFlo®
Company TYPENEX MEDICAL LLC
Model 6061
Device description ThermoFlo Heat and Moisture Exchanger, Elbow
Published 2026-01-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name BYD Condenser, Heat And Moisture (Artificial Nose)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10810050855812 Package GS1 100 In Commercial Distribution 00810050855815 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10810050855812 10810050855812 00810050855815 00810050855815 810050855815 0810050855815
GMDN Terms# Term, Definition table Term Definition Heat/moisture exchanger/microbial medical gas filter A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 600850213 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08904428744916 OSSEOUS- ShowerProtect EON MEDITECH PRIVATE LIMITED BYD 2026-03-13 08904428745067 OSSEOUS- TouchFree HME Series - Standard EON MEDITECH PRIVATE LIMITED BYD 2026-03-13 08904461000499 OSSEOUS-Heat Moisture Exchanger-Air EON MEDITECH PRIVATE LIMITED BYD 2026-03-13 10884389976067 MEDLINE MEDLINE INDUSTRIES, INC. BYD 2025-07-16 10859760005056 Passy Muir PASSY-MUIR, INC. BYD 2025-02-03 10810050855621 ThermoFlo® TYPENEX MEDICAL LLC BYD 2024-11-14 10193489024647 Medline MEDLINE INDUSTRIES, INC. BYD 2024-03-05 10850014574793 HME Flex PEPPER MEDICAL INC. BYD 2023-10-25 10884521082502 DAR Covidien LP BYD 2023-09-16 10884521829060 DAR Covidien LP BYD 2023-09-16 10884521829152 DAR Covidien LP BYD 2023-09-16 10884521829183 DAR Covidien LP BYD 2023-09-16 10884521829190 DAR Covidien LP BYD 2023-09-16 10884521829206 DAR Covidien LP BYD 2023-09-16 10884521829213 DAR Covidien LP BYD 2023-09-16 10884521829220 DAR Covidien LP BYD 2023-09-16 10884521829176 DAR Covidien LP BYD 2023-09-01 07331791008320 HME DigiTop O2 Atos Medical AB BYD 2022-12-07 07331791015564 Provox Life Coming Home USA Atos Medical AB BYD 2022-11-29 10840330700181 Procure Twin Med, LLC BYD 2022-11-02 10190752105898 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-09-05 10190752105928 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-09-05 10190752141964 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-09-05 10190752141988 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-09-05 10190752139794 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22 10190752139800 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22 10190752139817 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22 10190752139824 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22 10190752139831 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22 10190752139992 AirLife™ VYAIRE MEDICAL, INC. BYD 2022-08-22