Identity
- Trade Name
- AMC FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- LEADWIRE, METAL PINCH to DIN PLUG, 40" GREEN, 10 EA FDA UDI
- Model / Reference
- KT-EDR2244 FDA UDI
- Description
- LEADWIRE, METAL PINCH to DIN PLUG, 40" GREEN, 10 EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593019460 FDA UDI
- 510(k) Number
- K992524 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
A comprehensive electrocardiographic lead set for clinical use, designed to conduct electrical signals from a patient's heart via an electrode attached to the surface of the chest or limbs. This reusable device is intended as an insulated wire(s) with a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement.
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
K992524 also covers:
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
- AMC — Advantage Medical Electronics, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI 50477bc5-d040-44bd-a72d-3616042330a5 35 fields · synced Jul 29, 2026