Identity
- Trade Name
- RespVent™ FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter. The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours. FDA UDI
- Model / Reference
- RTG-01002 FDA UDI
- Description
- RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter. The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours. FDA UDI
Identifiers
- Catalog Number
- RTG-01002 FDA UDI
- Primary DI / UDI-DI
- 00850108006035 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
Dimensions & Sizes
- Size
- Weight — 24 Gram FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
RespVent™ by Cutting Edge Hc Brands Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger/microbial medical gas filter.
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- 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
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
- Cutting Edge Hc Brands Llc
Sources (1)
- FDA UDI 9745d055-900e-4a82-9769-492b271974d9 37 fields · synced May 30, 2026