Identity
- Trade Name
- RespVent™ FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- RespVent Tracheostomy Heat Mousture Exchanger 1000 is a single use heat and moisture exchanger which transfers heat and humidity from the gas expired by the patient to the inspired gases. RespVent Trach HME 1000 is intended for use on patients who are breathing spontaneously through a tracheostomy tube. FDA UDI
- Model / Reference
- RTG-01050 FDA UDI
- Description
- RespVent Tracheostomy Heat Mousture Exchanger 1000 is a single use heat and moisture exchanger which transfers heat and humidity from the gas expired by the patient to the inspired gases. RespVent Trach HME 1000 is intended for use on patients who are breathing spontaneously through a tracheostomy tube. FDA UDI
Identifiers
- Catalog Number
- RTG-01050 FDA UDI
- Primary DI / UDI-DI
- 00850108006066 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 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
Yes
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, single-use
RespVent™ by Cutting Edge Hc Brands Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Cutting Edge Hc Brands Llc
Sources (1)
- FDA UDI cf7bc6d8-a505-4758-a2bd-a1b5fe91f704 36 fields · synced Jun 6, 2026