Infinity M300
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- INFINITY M300 EUDAMEDFDA UDIINFINITY® M300 EUDAMEDSHP UNT M300 PWT WPA2 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- MS18501 EUDAMEDFDA UDIMS25755 EUDAMEDFDA UDI307005VK13K010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098004183 EUDAMEDFDA UDI04049098048989 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752307005VK13K0108A EUDAMED
- Direct Marketing DI
- 04049098048989 EUDAMED04049098004183 EUDAMED
- FDA Product Code
- MHX FDA 510(k)FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)FDA UDI
- 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
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
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Infinity M300 is a physiological patient monitor designed for real-time cardiac and respiratory parameter monitoring, including arrhythmia detection and alarm capabilities. It falls under the category of cardiovascular monitoring devices, providing continuous vital sign assessment for patients in clinical settings.
This device is intended for use in hospital, critical care, and emergency settings, supplied as a reusable medical instrument. It operates in non-sterile environments and is classified as a Class II medical device under FDA regulations. The Infinity M300 is authorized through FDA 510(k) clearance and EU MDR compliance, with no indication of MRI compatibility or single-use specifications.
Frequently asked questions
Is the Infinity M300 designed for single-use or can it be reused in clinical settings?
The Infinity M300 is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning, disinfection, and maintenance. Since it operates in non-sterile environments, it is not intended for sterile procedures or single-use applications.
What types of clinical environments is the Infinity M300 intended for, and what parameters does it monitor?
The Infinity M300 is designed for hospital, critical care, and emergency settings, where continuous monitoring of cardiac and respiratory parameters is required. It includes arrhythmia detection and alarm capabilities, making it suitable for high-acuity areas where real-time vital sign assessment is critical.
How is the regulatory compliance of the Infinity M300 established, and what classification does it hold?
The Infinity M300 holds FDA 510(k) clearance and EU MDR compliance, confirming its regulatory authorization. Under FDA regulations, it is classified as a Class II medical device, which typically requires additional controls beyond general controls due to its role in monitoring critical patient parameters.
Does the Infinity M300 come in multiple models or sizes, and if so, how are they differentiated?
The provided data does not specify distinct models or sizes for the Infinity M300, but it is listed under OpenFDA product codes with multiple registration numbers, which may correspond to variations in features, software versions, or regional adaptations. For precise model differentiation, refer to Draeger Medical Systems’ official documentation or technical specifications.
What storage or handling requirements should be considered for the Infinity M300?
Since the Infinity M300 is a reusable, non-sterile device, it requires adherence to standard cleaning, disinfection, and maintenance protocols to ensure reliability and safety. Storage should follow manufacturer guidelines to protect against environmental damage, electrical interference, or contamination. Specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data but are typically outlined in the device’s operational manual.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200859 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (5)
- FDA 510(k) K200859 24 fields · synced Oct 6, 2026
- FDA UDI db0996f4-5c5e-4dbb-8adb-7d17bb32382e 34 fields · synced May 30, 2026
- FDA UDI 5b33d11f-bf83-4849-b493-493170837812 34 fields · synced May 30, 2026
- EUDAMED 02abe07f-deb2-4de8-b7c6-dc3e12d292c0 61 fields · synced Jul 17, 2026
- EUDAMED ee1fe013-2ad5-41fe-884e-c436edbb23d4 61 fields · synced Jul 20, 2026