OptoMonitor

FDA UDI

Class II (US FDA UDI)

by Opsens

Identity

Trade Name: OptoMonitor FDA UDI
Generic Name: Cardiac catheterization laboratory computer FDA UDI
Model / Reference: Handle Unit FDA UDI

Identifiers

Catalog Number: F2030 FDA UDI
Primary DI / UDI-DI: 07540184020300 FDA UDI
510(k) Number: K142598 FDA UDI
FDA Product Code: DXO FDA UDI
DQX FDA UDI
GMDN Term: Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2870 FDA UDI
870.1330 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac catheterization laboratory computer

OptoMonitor by Opsens — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K142598 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: Opsens

Sources (1)

FDA UDI 4db7a943-fba2-4950-b916-4cf0f97a1467 36 fields · synced May 31, 2026