Gateway Software Server VF9.0.1
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Gateway Software Server VF9.0.1 EUDAMEDFDA UDI
- Generic Name
- Bedside information system application software FDA UDI
- Model / Reference
- MS40545 EUDAMEDFDA UDI207022XK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675673408 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752207022XK19Z000D2 EUDAMED
- Direct Marketing DI
- 04048675673408 EUDAMED
- 510(k) Number
- K203579 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 VF9.0.1 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
K203579 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 (2)
- FDA UDI 046d5a72-7ba0-4ed8-8186-63bcfed8b252 33 fields · synced Aug 2, 2026
- EUDAMED a68067bb-c02f-4cb5-afaa-a2b084917311 61 fields · synced Aug 2, 2026