FDA.reportPublic FDA data

Heat/moisture exchanger, single-use

Definition
A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.
GUDID devices
378
Last updated
2026-10-04 01:44:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04026704347810HUDSON RCITELEFLEX INCORPORATEDIPN0406732018-09-15
04026704347865HUDSON RCITELEFLEX INCORPORATEDIPN0413842018-09-15
04026704347872HUDSON RCITELEFLEX INCORPORATEDIPN0413862018-09-15
04026704347919HUDSON RCITELEFLEX INCORPORATEDIPN0427802018-09-15
04026704347926HUDSON RCITELEFLEX INCORPORATEDIPN0427812018-09-15
04026704348145HUDSON RCITELEFLEX INCORPORATEDIPN0443862018-09-15
04026704348176HUDSON RCITELEFLEX INCORPORATEDIPN0444182018-09-15
04026704348190HUDSON RCITELEFLEX INCORPORATEDIPN0445292018-09-15
04026704390021HUDSON RCITELEFLEX INCORPORATEDIPN0444202018-09-15
00848530062316Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES0272024-07-31
00848530082017Sunset Healthcare Mini in-line HME, for neonatalSunset Healthcare Solutions, Inc.RES027NE2018-09-21
00848530083274Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027IL2024-06-28
00848530083298Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027IL-302024-06-28
00848530083434Sunset T HME with built-in Oxygen PortSunset Healthcare Solutions, Inc.RES027OP2018-09-20
00848530089054Sunset Flex HMESunset Healthcare Solutions, Inc.RES027FLEX2018-09-17
00848530096908Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027-302024-07-31
00848530096922Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027FLEX-402024-07-31
00848530096946Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027NE-102024-07-31
00848530096953Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027OP-302024-07-31
00848530103637Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027UOP2024-07-31
00848530106430Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027SG2026-08-15
00848530107284Heat Moisture ExchangerSunset Healthcare Solutions, Inc.RES027ILLV2025-08-19
04026704399048HUDSON RCITELEFLEX INCORPORATEDIPN0425962018-09-15
04026704399055HUDSON RCITELEFLEX INCORPORATEDIPN0425972018-09-15
04026704399062HUDSON RCITELEFLEX INCORPORATEDIPN0426002018-09-15
04026704399079HUDSON RCITELEFLEX INCORPORATEDIPN0426022018-09-15
04026704399086HUDSON RCITELEFLEX INCORPORATEDIPN0426052018-09-15
04026704399185HUDSON RCITELEFLEX INCORPORATEDIPN0426342018-09-15
14026704927453GIBECKTELEFLEX INCORPORATEDIPN9298052025-07-31
04719874951467Create BiotechCREATE BIOTECH CO., LTD.003-009-0012026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.003-011-0012026-07-16
00840117305885Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen PortDynarex Corporation303092021-04-22
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex TubeDynarex Corporation302022021-04-22
00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 TracheostomyDynarex Corporation303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 TracheostomyDynarex Corporation303052021-04-22
08904428798292OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDEA9100112026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDEA910012026-03-13
04710810101939N/AGALEMED CORPORATIONHF142026-03-04
44710810101913N/AGALEMED CORPORATIONHF122026-03-04
10848530107281Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.RES027ILLV2025-08-19
34026704928935GIBECKTELEFLEX INCORPORATEDIPN9297992025-08-18
34026704928942GIBECKTELEFLEX INCORPORATEDIPN9298002025-08-18
34026704928959GIBECKTELEFLEX INCORPORATEDIPN9298862025-08-18
34026704928966GIBECKTELEFLEX INCORPORATEDIPN9298872025-08-18
34026704928973GIBECKTELEFLEX INCORPORATEDIPN9298882025-08-18
34026704928980GIBECKTELEFLEX INCORPORATEDIPN9298892025-08-18
24026704927467GIBECKTELEFLEX INCORPORATEDIPN9298062025-07-31
24026704927740GIBECKTELEFLEX INCORPORATEDIPN9299142025-07-31
24026704929010GIBECKTELEFLEX INCORPORATEDIPN9295032025-07-31
24026704929522GIBECKTELEFLEX INCORPORATEDIPN9298032025-07-31
34026704927457GIBECKTELEFLEX INCORPORATEDIPN9298052025-07-31
34026704929024GIBECKTELEFLEX INCORPORATEDIPN9295042025-07-31
34026704929031GIBECKTELEFLEX INCORPORATEDIPN9295052025-07-31
34026704929536GIBECKTELEFLEX INCORPORATEDIPN9298042025-07-31
34026704929864GIBECKTELEFLEX INCORPORATEDIPN9298262025-07-31
24026704929041GIBECKTELEFLEX INCORPORATEDIPN9295062025-07-30
20884389976064MEDLINEMEDLINE INDUSTRIES, INC.DYNJAPHME342025-07-16
04035324011704TRACOE® modularTracoe medical GmbHREF 6452015-10-18
04035324019489TRACOE® modularTracoe medical GmbHREF 6432015-10-18
04035324054718TRACOE® modularTracoe medical GmbHREF 640-S2015-10-18
10889483586532AirLife™AirLife Finland Oy5570050002025-03-28
10889483586587AirLife™AirLife Finland Oy5570445002025-03-28
10889483586594AirLife™AirLife Finland Oy5570552002025-03-28
10889483586600AirLife™AirLife Finland Oy5570562002025-03-28
10889483586617AirLife™AirLife Finland Oy5570572002025-03-28
10889483586679AirLife™AirLife Finland Oy5570850002025-03-28
30889483586901AirLife™Sunmed Group Holdings, LLC5701EU2025-02-19
30889483586918AirLife™Sunmed Group Holdings, LLC5702EU2025-02-19
30889483586925AirLife™ Hygroscopic Condenser HumidifierSunmed Group Holdings, LLC5704EU2025-02-19
30889483586932AirLife™Sunmed Group Holdings, LLC57052025-02-19
30889483586949AirLife™Sunmed Group Holdings, LLC57062025-02-19
30889483586956AirLife™Sunmed Group Holdings, LLC57082025-02-19
30889483586963AirLife™Sunmed Group Holdings, LLC5708HEPA2025-02-19
30889483587007AirLife™Sunmed Group Holdings, LLC5722EU2025-02-19
00859760005059Passy Muir PASSY-MUIR, INC.PM-HME2025-02-03
04035324016945TRACOE modularTracoe medical GmbHREF 6412015-10-18
04035324016952TRACOE modularTracoe medical GmbHREF 6422015-10-18
04035324054817TRACOE modularTracoe medical GmbHREF 640-CT2015-10-18
20848530062310Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.RES0272024-07-31
20848530096926Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.RES027FLEX-402024-07-31