Identity
- Trade Name
- Hemomed Pod EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, invasive FDA UDI
- Model / Reference
- 5588822 EUDAMEDFDA UDI008549 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098008549 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098008549 EUDAMED
- 510(k) Number
- K070566 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Patient monitoring system module, blood pressure, invasive 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, blood pressure, invasive
Hemomed Pod by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, blood pressure, invasive.
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
- FMT — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 36b31dda-c093-46d0-9da0-db9454f2cb5c 34 fields · synced Oct 7, 2026
- EUDAMED 6821444d-e83a-4c1a-ad0a-a8822e43ea20 61 fields · synced Oct 7, 2026