Identity
- Trade Name
- ECG Limb 5-L Radiotransl, 1.5M FDA UDI
- Generic Name
- Radiolucent electrocardiographic lead FDA UDI
- Model / Reference
- 5734418 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098008242 FDA UDI
- 510(k) Number
- K070566 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Radiolucent electrocardiographic lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiolucent electrocardiographic lead
ECG Limb 5-L Radiotransl, 1.5M by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiolucent electrocardiographic lead.
- Multi-Link™ — Airlife, Inc. · Class II
- Kendall — Cardinal Health 200, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- ECG Lead Wires — Ivy Biomedical Systems, Inc. · Class II
- Kendall — Cardinalhealth · Class II
- Kendall — Cardinal Health 200, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- ECG Lead Wires — Ivy Biomedical Systems, Inc. · 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI 1757905b-1ce6-4938-9971-759c82685ccd 34 fields · synced Jun 9, 2026