Infinity MultiMed 12 Pod
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- POD MULTIMED 12-Lead + SpO2 EUDAMEDInfinity MultiMed 12 Pod FDA UDI
- Generic Name
- Patient monitoring system module, electroencephalographic FDA UDI
- Model / Reference
- 5589663 EUDAMEDFDA UDI008525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098008525 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098008525 EUDAMED
- 510(k) Number
- K070566 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Patient monitoring system module, electroencephalographic 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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Patient monitoring system module, electroencephalographic
Infinity MultiMed 12 Pod by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K070566 also covers:
- CARDIAC OUTPUT KIT BAXTER — Draeger Medical Systems, Inc.
- Delta Monitor — Draeger Medical Systems, Inc.
- DeltaXL Monitor — Draeger Medical Systems, Inc.
- ECG 3 lead, Euro, Telemetry — Draeger Medical Systems, Inc.
- ECG 3-LEAD DUAL-PIN AHA/US, 1M — Draeger Medical Systems, Inc.
- ECG 5 lead Euro Telemetry — Draeger Medical Systems, Inc.
- ECG 5-LEAD SINGLE-PIN AHA, 1M — Draeger Medical Systems, Inc.
- ECG 5-LEAD TRUST AHU/US, TELEM — Draeger Medical Systems, Inc.
- ECG 6-LEAD SINGLE-PIN AHA, 1M — Draeger Medical Systems, Inc.
- ECG 6-LEAD TRUST AHA/US, TELEM — Draeger Medical Systems, Inc.
- ECG 6-Lead, Dual-P Euro 1M — Draeger Medical Systems, Inc.
- ECG CBL 4-LD SINGLE-PIN EUR 1M — Draeger Medical Systems, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 77180207-b491-42e6-84cc-e1bf24f2d72b 34 fields · synced Jul 9, 2026
- EUDAMED e3fb09b9-d443-4858-a606-762b50f0c6c1 61 fields · synced Jul 9, 2026