Amc

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name: AMC FDA UDI
Generic Name: Electrocardiographic electrode connector FDA UDI
Device Name: LEADWIRE, SNAP to DIN PLUG, 24" RED, 10 EA FDA UDI
Model / Reference: KT-EDR1221 FDA UDI
Description: LEADWIRE, SNAP to DIN PLUG, 24" RED, 10 EA FDA UDI

Identifiers

Primary DI / UDI-DI: 00849593018869 FDA UDI
510(k) Number: K992524 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Electrocardiographic electrode connector 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiographic electrode connector

Amc by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode connector.

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CBL 024, PLP, TWINPIN, 5LEAD, YOKE10FT, AHA — CURBELL MEDICAL PRODUCTS, INC. · Class II
SurePower 4 — Zoll Medical Corporation · Class III
3-LD ECG CABLE, MOLDED, SNAP, A, RISISTO — CURBELL MEDICAL PRODUCTS, INC. · Class II
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ZENIX — Zoll Medical Corporation · Class III

Cleared under the same submission

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 eded3826-f9e2-4041-bb14-a231504e0dfa 35 fields · synced May 30, 2026