Identity
- Trade Name
- RespVent™ FDA UDI
- Generic Name
- Heat/moisture exchanger insertable filter FDA UDI
- Device Name
- RespVent Universal Bacteria Viral Respiratory Filter is a disposable single-use device indicated for patient during the delivery of ventilator gases. They provide filtration for reducing possible cross contamination between patient and equipment. The RespVent Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The RespVent Filter can be used on adult patients. The RespVent Filter is indicated for use by qualified medical personnel only. The RespVent Filter is designed for disposable use and should be changed at least every 24 hours. FDA UDI
- Model / Reference
- RTG-01100 FDA UDI
- Description
- RespVent Universal Bacteria Viral Respiratory Filter is a disposable single-use device indicated for patient during the delivery of ventilator gases. They provide filtration for reducing possible cross contamination between patient and equipment. The RespVent Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The RespVent Filter can be used on adult patients. The RespVent Filter is indicated for use by qualified medical personnel only. The RespVent Filter is designed for disposable use and should be changed at least every 24 hours. FDA UDI
Identifiers
- Catalog Number
- RTG-01100 FDA UDI
- Primary DI / UDI-DI
- 00850108006097 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger insertable 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 — 20 Gram FDA UDI
Category: Heat/moisture exchanger insertable 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 insertable filter.
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- DAR — Covidien LP · Class II
- HME Filters — CORVENT MEDICAL, INC · 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 5693ce4e-7b94-44e0-925e-b6d8ad69727c 37 fields · synced May 31, 2026