Identity
- Trade Name
- RespVent™ FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- RespVent HME 1500 Heat Mousture Exchanger is indicated to provide heat and moisture by capturing expired heat and moisture and returning it to the patients lungs via inspired gases. FDA UDI
- Model / Reference
- RTG-01004 FDA UDI
- Description
- RespVent HME 1500 Heat Mousture Exchanger is indicated to provide heat and moisture by capturing expired heat and moisture and returning it to the patients lungs via inspired gases. FDA UDI
Identifiers
- Catalog Number
- RTG-01004 FDA UDI
- Primary DI / UDI-DI
- 00850108006059 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 8aa43cae-a25c-441c-bbe4-54410ead7b02 35 fields · synced May 31, 2026