Med-Dyne

FDA UDI

Class II (US FDA UDI)

by Med-Dyne

Identity

Trade Name: Med-Dyne FDA UDI
Generic Name: Electrocardiographic lead set, single-use FDA UDI
Device Name: LARGE PRE-WIRED HYDRO GEL ELECTRODE 36" LONG LEAD WIRE - SET OF 5 FDA UDI
Model / Reference: G536L FDA UDI
Description: LARGE PRE-WIRED HYDRO GEL ELECTRODE 36" LONG LEAD WIRE - SET OF 5 FDA UDI

Identifiers

Primary DI / UDI-DI: 00817497020608 FDA UDI
510(k) Number: K080112 FDA UDI
FDA Product Code: DSA FDA UDI
GMDN Term: Electrocardiographic lead set, single-use 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

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size: Length — 36 Inch FDA UDI

Category: Electrocardiographic electrode, single-use Electrocardiographic lead set, single-use

Med-Dyne by Med-Dyne — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, single-use.

APK — Apk Technology · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
Philips — Apk Technology · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
SureLead — Authentic Medical · Class II
9Line — RISING EAGLE MEDICAL · Class II
Multi-Link™ — Airlife, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Cleared under the same submission

K080112 also covers:

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: Med-Dyne

Sources (1)

FDA UDI 1b903842-b84a-4eda-b81d-da5efeb61308 36 fields · synced Jun 1, 2026