Identity
- Trade Name
- Inspiration EUDAMEDINSPIRATION 7i Ventilator FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- Inspiration Ventilator EUDAMEDINSPIRATION 7i Ventilator System, 17" screen FDA UDI
- Model / Reference
- Inspiration EUDAMEDF7300000 EUDAMEDINSPIRATION 7i Ventilator 17" screen FDA UDI
- Description
- INSPIRATION 7i Ventilator System, 17" screen FDA UDI
Identifiers
- Catalog Number
- F7300000-7i-F, F7300000-7i-L FDA UDI
- Primary DI / UDI-DI
- 00860008873637 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860008873637 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Inspiration by eVent Medical, Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860008873637 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eVent Medical Ltd.
- EUDAMED SRN
- US-MF-000027969
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 410f19cb-a3b8-41cc-a075-35a2d803b5ac 61 fields · synced Jun 8, 2026
- FDA UDI 321e5fee-5b1b-4d0f-bf69-1020327963cb 35 fields · synced May 30, 2026