Identity
- Trade Name
- AMC FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- 5 LEAD REUSABLE DIN TO PINCH, SHIELD, 29"/51", SS, AHA FDA UDI
- Model / Reference
- LW-3090SMX/5AT FDA UDI
- Description
- 5 LEAD REUSABLE DIN TO PINCH, SHIELD, 29"/51", SS, AHA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593000819 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic lead set, reusable
Amc by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- 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
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
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
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI 03398ad6-1c75-42d1-89fa-296b46c85cd1 35 fields · synced May 31, 2026