EKG Patch™ (Medium)

FDA UDI

Class II (US FDA UDI)

by Nuline Sensors, Llc

Identity

Trade Name: EKG Patch™ (Medium) FDA UDI
Generic Name: Ambulatory recorder conductive patch FDA UDI
Device Name: Electrode, Electrocardiograph FDA UDI
Model / Reference: Medium FDA UDI
Description: Electrode, Electrocardiograph FDA UDI

Identifiers

Catalog Number: MGMED FDA UDI
Primary DI / UDI-DI: 00850018485005 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Ambulatory recorder conductive patch 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ambulatory recorder conductive patch

EKG Patch™ (Medium) by Nuline Sensors, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory recorder conductive patch.

EKG Patch (Medium) — MG MEDICAL PRODUCTS LLC · Class II
PILLING — TELEFLEX INCORPORATED · Class I
EKG Patch (Pediatric 2) — MG MEDICAL PRODUCTS LLC · Class II
EKG Patch (Pediatric 1) — MG MEDICAL PRODUCTS LLC · Class II
Universal electrode patch — Braemar Manufacturing, LLC · Class II
Universal electrode-patch — Braemar Manufacturing, LLC · Class II
EKG Patch (Pediatric 3) — MG MEDICAL PRODUCTS LLC · Class II
EKG Patch (Large) — MG MEDICAL PRODUCTS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nuline Sensors, Llc

Sources (1)

FDA UDI 81b2f458-b454-4d13-8873-3cdf01fc343c 36 fields · synced Jun 1, 2026