Identity
- Trade Name
- HME with Flex Tubes FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 31161 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M4853116117 FDA UDI
- 510(k) Number
- K192713 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
HME with Flex Tubes by Meditera Tibbi Malzeme Sanayi Ve Ticaret Anonim Sirketi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger/microbial medical gas filter.
- Ulti-MistHME/F Angled — KING SYSTEMS CORPORATION. · Class II
- AirLife™ — Airlife, Inc. · Class I
- DAR — Covidien LP · Class I
- Disposable Anesthesia Circuit — WESTMED, INC. · Class I
- ThermoShield Adult Bacterial Viral HMEF — FLEXICARE MEDICAL LIMITED · Class II
- Hygrovent Gold Comfort — FLEXICARE MEDICAL LIMITED · Class II
- Typenex Heat and Moisture Exchanger — Typenex Medical, LLC · Class II
- Hsiner — Hsiner Company · Class II
Cleared under the same submission
K192713 also covers:
- Resp-O2 Advantage Filter- Universal Respiratory B/V Filter — Dynarex Corp.
- Resp-O2 Heat Moisture Exchanger & Filter (HMEF) 1500 w/ B/V Filter and CO2 Port — Dynarex Corp.
- Bacterial Viral Filter — MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
- Bacterial Viral Filter — MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
- Bacterial-Viral HME Filter — MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
- Heat Moisture Exchanger with Filter — MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 72fb7eb5-3536-4bc0-9433-b479e78b30a4 35 fields · synced May 30, 2026