OptiMap™ ECG Cables - NA

FDA UDI

Class II (US FDA UDI)

by Cortex, Inc.

Identity

Trade Name: OptiMap™ ECG Cables - NA FDA UDI
Generic Name: Cardiac mapping system reference patch FDA UDI
Device Name: OptiMap ECG Cables - North American FDA UDI
Model / Reference: FG0012-NA FDA UDI
Description: OptiMap ECG Cables - North American FDA UDI

Identifiers

Catalog Number: OPTI-ECG-NA FDA UDI
Primary DI / UDI-DI: 00850064686111 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Cardiac mapping system reference patch FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 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

Yes

FDA UDI

Category: Cardiac mapping system reference patch

OptiMap™ ECG Cables - NA by Cortex, Inc. — 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: Cortex, Inc.

Sources (1)

FDA UDI 4c86b803-4051-465e-8b75-8ba8d5a6816b 34 fields · synced Jun 1, 2026