HEMO/PICCO POD adapter, 10PIN
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- HEMO/PICCO POD ADAPTER, 10POL EUDAMEDHEMO/PICCO POD adapter, 10PIN FDA UDI
- Generic Name
- Patient monitoring system module, cardiac output FDA UDI
- Model / Reference
- 3375958 EUDAMEDFDA UDI1070276K19Z310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098009485 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867521070276K19Z310U6 EUDAMED
- 510(k) Number
- K073113 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, cardiac output FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 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
No
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, cardiac output
HEMO/PICCO POD adapter, 10PIN by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, cardiac output.
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Cleared under the same submission
K073113 also covers:
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 19dccebd-f1b3-412f-94bd-53a0125dee6c 34 fields · synced Jun 18, 2026
- EUDAMED 04727f92-4dda-4275-9807-e1eec109c1f9 61 fields · synced Jun 18, 2026