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Infinity Gateway Suite VF4

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K043549Ref MS11700Model 2207022XK19Z01

by Draeger Medical Systems, Inc.

Identity

Trade Name
Infinity Gateway EUDAMED
Infinity Gateway USB Dongle FDA UDI
Generic Name
Bedside information system application software FDA UDI
Model / Reference
MS11700 EUDAMEDFDA UDI
2207022XK19Z01 EUDAMED

Identifiers

Primary DI / UDI-DI
04049098007061 EUDAMEDFDA UDI
Basic UDI-DI
040486752207022XK19Z010D5 EUDAMED
510(k) Number
K043549 FDA 510(k)
K233834 FDA UDI
FDA Product Code
MHX FDA 510(k)
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 EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
870.2300 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Infinity Gateway Suite VF4 is a physiological patient monitor designed for arrhythmia detection and alarm functionality, classified as a Class II medical device. It integrates with clinical information systems to facilitate data exchange between monitoring and therapy devices, laboratory systems, and electronic medical records, enabling comprehensive patient monitoring and care coordination.

This device is intended for use in clinical settings, including hospitals, to support data integration across healthcare information systems. It is supplied as a reusable system and complies with healthcare information exchange protocols. The Infinity Gateway Suite VF4 holds FDA 510(k) clearance (K043549) under the Special 510(k) program and is authorized under the Medical Devices Regulation (MDR). No sterility or MRI safety information is specified.

Frequently asked questions

What is the primary purpose of the Infinity Gateway Suite VF4 in a clinical setting?

The Infinity Gateway Suite VF4 is designed as a physiological patient monitor with a focus on arrhythmia detection and alarm functionality. Its key role is to integrate with other clinical systems—such as monitoring devices, therapy equipment, lab systems, and electronic medical records—to enable seamless data exchange. This integration supports comprehensive patient monitoring and improves care coordination in hospital environments.

Is the Infinity Gateway Suite VF4 intended for single-use or reusable applications?

The Infinity Gateway Suite VF4 is explicitly supplied as a reusable system. It is not designed for single-use, meaning it can be cleaned, disinfected, and reused across multiple patients in clinical settings.

How does the Infinity Gateway Suite VF4 connect with other healthcare systems?

The Infinity Gateway Suite VF4 complies with healthcare information exchange protocols, allowing it to integrate with clinical information systems. This enables data sharing between monitoring and therapy devices, laboratory systems, and electronic medical records, facilitating coordinated patient care.

What regulatory pathways has the Infinity Gateway Suite VF4 followed for approval?

The Infinity Gateway Suite VF4 holds FDA clearance under the Special 510(k) program (K043549) and is authorized under the Medical Devices Regulation (MDR). The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and is classified as a Class II medical device.

Does the Infinity Gateway Suite VF4 require any special handling or storage conditions?

The Infinity Gateway Suite VF4 is a reusable system, so it must be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene. While no specific sterility or MRI safety information is provided, standard infection control protocols for reusable medical devices should be followed. Storage should be in a clean, dry environment as recommended by Draeger Medical Systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Infinity® Gateway Suite | Draeger, INFINITY GATEWAY SUITE, VF4 (K043549) — FDA 510(k) | Innolitics, INFINITY GATEWAY SUITE, VF4 510 (k) K043549 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Draeger Medical Systems, Inc.

Sources (3)

  • FDA 510(k) K043549 24 fields · synced Oct 6, 2026
  • FDA UDI 680e600a-73c2-43a8-ba3f-93b347b622eb 33 fields · synced May 30, 2026
  • EUDAMED 089a3687-9c72-42c9-a7e8-1f73b626f20a 61 fields · synced Jul 19, 2026