Gateway Software Server VF9.1.2
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Gateway Software Server VF9.1.2 EUDAMEDFDA UDIGATEWAY SOFTWARE SERVER VF9.1 EUDAMED
- Generic Name
- Bedside information system application software FDA UDI
- Model / Reference
- 3736376 EUDAMEDFDA UDI207022XK19Z000 EUDAMEDMS41190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675777762 EUDAMEDFDA UDI04048675757375 EUDAMED
- Basic UDI-DI
- 040486752207022XK19Z000D2 EUDAMED
- Direct Marketing DI
- 04048675757375 EUDAMED04048675777762 EUDAMED
- 510(k) Number
- K233834 FDA UDI
- FDA Product Code
- MSX FDA UDI
- EMDN Code
- Z12039092 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Bedside information system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Bedside information system application software
Gateway Software Server VF9.1.2 by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K233834 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Draeger Medical Systems, Inc.
Sources (3)
- FDA UDI cb0e3a0b-7fc9-41df-b8f6-7f244e2ad7ea 33 fields · synced Sep 18, 2026
- EUDAMED 2dc20473-794b-49aa-994a-fc08890bb058 61 fields · synced Jul 10, 2026
- EUDAMED 1735dd5e-4f71-4a58-8164-6782e8c2bb69 61 fields · synced Sep 18, 2026