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Babylog VN800
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8422200Model 304023FK19Z000
Identity
- Trade Name
- Babylog VN600 EUDAMEDFDA UDIBabylog VN800 FDA UDI
- Generic Name
- Neonatal intensive-care ventilator FDA UDI
- Model / Reference
- 8422200 EUDAMEDFDA UDI304023FK19Z000 EUDAMED8422400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675551713 EUDAMEDFDA UDI04048675542476 FDA UDI
- Basic UDI-DI
- 040486751304023FK19Z000XD EUDAMED
- Direct Marketing DI
- 04048675551713 EUDAMED
- 510(k) Number
- K222207 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010503 NEONATAL/PAEDIATRIC PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Neonatal 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 intensive-care ventilator
Babylog VN800 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Neonatal intensive-care ventilator.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (3)
- FDA UDI 3fbaa378-9bb4-476c-95b5-f750e10c6c51 33 fields · synced Jun 20, 2026
- FDA UDI 280ca7ca-e6a6-4794-89ad-03ce4d14da87 33 fields · synced May 30, 2026
- EUDAMED 75fff1cb-ba86-4f58-9476-b35b9e55c7bd 61 fields · synced Jun 20, 2026