Identity
- Trade Name
- Evita V800 EUDAMEDFDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Model / Reference
- 8422500 EUDAMEDFDA UDI304022FK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675542148 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751304022FK19Z000WN EUDAMED
- Direct Marketing DI
- 04048675542148 EUDAMED
- 510(k) Number
- K222024 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS 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
- Germany 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
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
MR Unsafe FDA UDI
Category: Neonatal/adult intensive-care ventilator
Evita V800 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K222024 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 11061d62-8657-43f7-89a9-97c41aa6e77b 33 fields · synced Oct 6, 2026
- EUDAMED 4ea19d43-cbe0-46d8-9776-8dd78b1ef5fe 61 fields · synced Jul 12, 2026