Identity
- Trade Name
- ECG Lead Wires FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Lead Wires, Metallic, 3 Lead Set, AHA, 30 in FDA UDI
- Model / Reference
- 590424 FDA UDI
- Description
- ECG Lead Wires, Metallic, 3 Lead Set, AHA, 30 in FDA UDI
Identifiers
- Catalog Number
- 590424 FDA UDI
- Primary DI / UDI-DI
- 00816396021662 FDA UDI
- 510(k) Number
- K942321 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
Category: Electrocardiographic lead set, reusable
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 Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K942321 also covers:
- Cadwell Patch Electrode with Snap Connector — Cadwell Industries, Inc.
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- 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 Patient Cable — Ivy Biomedical Systems, Inc.
- ECG Patient Cable — Ivy Biomedical Systems, Inc.
- ECG Patient Cable — 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 |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA UDI b7301ece-d006-4844-a1e9-ff866c77041f 37 fields · synced Jun 9, 2026