Matrix Mini ECG Module Kit

FDA UDI

Class II (US FDA UDI)

by Global Instrumentation, Llc

Identity

Trade Name: Matrix Mini ECG Module Kit FDA UDI
Generic Name: Electrocardiographic monitor FDA UDI
Device Name: Module + USB + Patient Cable 3L IEC 90815187020016; ECG Module 90815187020078; Patient Cable 3L IEC 90815187020023; ECG Module USB Cable (18") 90815187020030; ECG Mounting Accessory, ACM, WALL FDA UDI
Model / Reference: 6000-ECG3I FDA UDI
Description: Module + USB + Patient Cable 3L IEC 90815187020016; ECG Module 90815187020078; Patient Cable 3L IEC 90815187020023; ECG Module USB Cable (18") 90815187020030; ECG Mounting Accessory, ACM, WALL FDA UDI

Identifiers

Catalog Number: 6000-ECG3I FDA UDI
Primary DI / UDI-DI: 90815187020047 FDA UDI
FDA Product Code: DSI FDA UDI
GMDN Term: Electrocardiographic monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1025 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

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic monitor

Matrix Mini ECG Module Kit by Global Instrumentation, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Global Instrumentation, Llc

Sources (1)

FDA UDI 7470446e-80b8-4226-819f-7f4885f19ff4 34 fields · synced Jun 1, 2026