ECG Cbl MonoLead 4 AHA/US 1.7m
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EKG Kbl MonoLead 4 AHA/US 1,7m EUDAMEDECG Cbl MonoLead 4 AHA/US 1.7m FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Model / Reference
- MS14694 EUDAMEDFDA UDI1070256K19Z190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098006057 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867521070256K19Z190T6 EUDAMED
- 510(k) Number
- K070566 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I 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
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
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
ECG Cbl MonoLead 4 AHA/US 1.7m 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 Electrocardiographic lead set, reusable.
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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
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 400f496a-5965-45d5-9452-6ae6f2fb2e5a 34 fields · synced Jul 19, 2026
- EUDAMED 09bf5af4-eb32-4f85-a60e-3a0ba20c65c9 61 fields · synced Jul 19, 2026