Infinity M500 With Power
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- INFINITY® M500 DOCKING STATION EUDAMEDINFINITY M500 WITH POWER FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- MS20407 EUDAMEDFDA UDI2307028XK13Z03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098054447 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752307028XK13Z030GW EUDAMED
- Direct Marketing DI
- 04049098054447 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- 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
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
Infinity M500 With Power by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 db563e7d-b2ac-44cd-bb76-8eb487af6b3f 33 fields · synced Jun 18, 2026
- EUDAMED 92b684c5-6a2a-4d4a-9bc0-71e4135f93aa 61 fields · synced Jun 18, 2026