Identity
- Trade Name
- Ventrain FDA UDI
- Generic Name
- Manual jet ventilation device FDA UDI
- Device Name
- Ventrain® is the only ventilation device that provides full ventilation in "Cannot Intubate, Cannot Ventilate" situations. Ventrain® not only supplies oxygen during the inspiration phase, but also uses suction to actively remove gas from the lungs during the expiration phase. This active expiration has been named Expiratory Ventilation Assistance (EVA®). Ventrain® is a single-use ventilation device specifically designed for difficult or obstructed airway situations. Based on EVA® it offers 1) effective, full ventilation of a patient with an obstructed upper airway, and 2) more therapeutic options in cases involving difficult airways. See further www.ventinova.nl/products/ventrain. FDA UDI
- Model / Reference
- 2618700 FDA UDI
- Description
- Ventrain® is the only ventilation device that provides full ventilation in "Cannot Intubate, Cannot Ventilate" situations. Ventrain® not only supplies oxygen during the inspiration phase, but also uses suction to actively remove gas from the lungs during the expiration phase. This active expiration has been named Expiratory Ventilation Assistance (EVA®). Ventrain® is a single-use ventilation device specifically designed for difficult or obstructed airway situations. Based on EVA® it offers 1) effective, full ventilation of a patient with an obstructed upper airway, and 2) more therapeutic options in cases involving difficult airways. See further www.ventinova.nl/products/ventrain. FDA UDI
Identifiers
- Catalog Number
- 2618700 FDA UDI
- Primary DI / UDI-DI
- 08718969590044 FDA UDI
- 510(k) Number
- K132759 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Manual jet ventilation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Manual jet ventilation device
Ventrain by Ventinova Medical B.V. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ventinova Medical B.V.
Sources (1)
- FDA UDI 2a8b6005-5fcc-4395-8254-f2392f240fdb 36 fields · synced May 30, 2026