Identity
- Trade Name
- Inspiration 7i Ventilator System FDA UDI
- Generic Name
- General-purpose intensive-care ventilator FDA UDI
- Device Name
- Inspiration Ventilator System, model 7i with 17" Display Panel FDA UDI
- Model / Reference
- Inspiration Ventilator System FDA UDI
- Description
- Inspiration Ventilator System, model 7i with 17" Display Panel FDA UDI
Identifiers
- Catalog Number
- F7300000-7i-L-US FDA UDI
- Primary DI / UDI-DI
- B079EVM11000101US0 FDA UDI
- 510(k) Number
- K130178 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- General-purpose intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose intensive-care ventilator
Inspiration 7i Ventilator System by eVent Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose intensive-care ventilator.
- Drawer for Low mobile carts — Maquet Critical Care AB · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
- eVolution 3e Ventilator — eVent Medical, Ltd. · Class II
- EVOLUTION — eVent Medical, Ltd. · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
Cleared under the same submission
K130178 also covers:
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
- eVent Medical, Ltd.
Sources (1)
- FDA UDI 5c753e04-3c5f-468d-923f-5bf7e8bd301e 36 fields · synced Jun 8, 2026