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Resp-O2 Heat Moisture Exchanger & Filter (HMEF) 1500 w/ B/V Filter and CO2 Port
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Heat Moisture Exchanger & Filter (HMEF) 1500 w/ B/V Filter and CO2 Port FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- Adult, Vidal volume Range (150-1500mL), Breathing Resistance (1.7cm H2O at 60L/min), Media (Foam), Dead Space (55mL), Weight (28.5g) FDA UDI
- Model / Reference
- 30102 FDA UDI
- Description
- Adult, Vidal volume Range (150-1500mL), Breathing Resistance (1.7cm H2O at 60L/min), Media (Foam), Dead Space (55mL), Weight (28.5g) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117305847 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
Resp-O2 Heat Moisture Exchanger & Filter (HMEF) 1500 w/ B/V Filter and CO2 Port by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID
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
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- 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.
- 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
- HME with Flex Tubes — 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
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 066bd923-2135-455f-956b-81059abe51d7 34 fields · synced May 31, 2026