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S/W SUB VF9.0 Gateway

FDA UDI

Class II (US FDA UDI)

by Draeger Medical Systems, Inc.

Identity

Trade Name
S/W SUB VF9.0 Gateway FDA UDI
Generic Name
Bedside information system application software FDA UDI
Model / Reference
MS40046 FDA UDI

Identifiers

Primary DI / UDI-DI
04049098099264 FDA UDI
510(k) Number
K203579 FDA UDI
FDA Product Code
MSX FDA UDI
GMDN Term
Bedside information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bedside information system application software

S/W SUB VF9.0 Gateway by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bedside information system application software.

Cleared under the same submission

K203579 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Draeger Medical Systems, Inc.

Sources (1)

  • FDA UDI 253ccaf7-c0c7-418d-bd6c-451940e29d42 33 fields · synced Jun 9, 2026