Infinity Mcable-Nellcor Oximax
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- INFINITY MCABLE-NELLCOR OXIMAX EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Model / Reference
- MS20668 EUDAMEDFDA UDI307028VK19K010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098049665 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752307028VK19K010EB EUDAMED
- Direct Marketing DI
- 04049098049665 EUDAMED
- 510(k) Number
- K113798 FDA UDI
- FDA Product Code
- DQA FDA UDIMHX FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.1025 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
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Patient monitoring system module, pulse oximetry
Infinity Mcable-Nellcor Oximax by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, pulse oximetry.
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Cleared under the same submission
K113798 also covers:
- IACS w/C500 — Draeger Medical Systems, Inc.
- IACS w/C700 — Draeger Medical Systems, Inc.
- INFINITY MASIMO SET MOUNT KIT — Draeger Medical Systems, Inc.
- INFINITY MCABLE-ANALOG/SYNC — Draeger Medical Systems, Inc.
- INFINITY MCABLE-DUAL HEMO — Draeger Medical Systems, Inc.
- INFINITY MCABLE-MASIMO SET — Draeger Medical Systems, Inc.
- INFINITY MCABLE-RAINBOW SET — Draeger Medical Systems, Inc.
- Infinity Mpod Quad Hemo — Draeger Medical Systems, Inc.
- M540 Hemo Connect Cable, 1.5 m — Draeger Medical Systems, Inc.
- M540 Hemo Connect Cable, 2.9 m — Draeger Medical Systems, Inc.
- Masimo Rainbow SET MCable — Draeger Medical Systems, Inc.
- SHP UNT INFINITY M540 — Draeger Medical Systems, Inc.
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 8a2198dc-c065-4bb2-bf1e-57da45414259 34 fields · synced Jun 20, 2026
- EUDAMED 1487da14-47d3-45ed-999a-d594e975ee0b 61 fields · synced Jun 20, 2026