Identity
- Trade Name
- Safety Lead Wire .080" FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Individual patient lead wire for Abbott Electrophysiology application. FDA UDI
- Model / Reference
- 41859 FDA UDI
- Description
- Individual patient lead wire for Abbott Electrophysiology application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 90817266020627 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
Yes
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 9 Feet FDA UDI
Category: Electrocardiographic lead set, reusable
Safety Lead Wire .080" by Merit Cables Incorporated — 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
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- 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 Lead Wires — 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
- Merit Cables Incorporated
Sources (1)
- FDA UDI 3f885080-25fa-4b28-9829-793fbb144323 36 fields · synced Jun 1, 2026