Identity
- Trade Name
- ECG Lead Wires FDA UDI
- Generic Name
- Radiolucent electrocardiographic lead FDA UDI
- Device Name
- ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 30 in FDA UDI
- Model / Reference
- 590377 FDA UDI
- Description
- ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 30 in FDA UDI
Identifiers
- Catalog Number
- 590377 FDA UDI
- Primary DI / UDI-DI
- 00816396021877 FDA UDI
- 510(k) Number
- K970755 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Radiolucent electrocardiographic lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
Category: Radiolucent electrocardiographic lead
ECG Lead Wires by Ivy Biomedical 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
- Kendall — Cardinalhealth · Class II
- Kendall — Cardinal Health 200, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
Cleared under the same submission
K970755 also covers:
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical Systems, Inc.
- ECG Lead Wires — Ivy Biomedical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA UDI 42145a67-c244-43ec-958b-94f2c8073287 37 fields · synced Jun 9, 2026