Retia Medical

FDA UDI

Class II (US FDA UDI)

by Retia Medical, LLC

Identity

Trade Name: Retia Medical FDA UDI
Generic Name: Noninvasive haemodynamic monitoring system FDA UDI
Device Name: The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room. FDA UDI
Model / Reference: FG-001 FDA UDI
Description: The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001506402 FDA UDI
510(k) Number: K181372 FDA UDI
FDA Product Code: DXG FDA UDI
GMDN Term: Noninvasive haemodynamic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1435 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

Yes

FDA UDI

Category: Noninvasive haemodynamic monitoring system

Retia Medical by Retia Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive haemodynamic monitoring system.

Braun — KAZ USA, INC. · Class II
Drive — Drive Devilbiss Healthcare · Class II
Wrist Blood Pressure Monitor — GENERATION GUARD PTY LTD · Class II
Arm Blood Pressure Monitor — GENERATION GUARD PTY LTD · Class II
Retia Medical — Retia Medical, LLC · Class II
Retia Medical — Retia Medical, LLC · Class II
Retia Medical — Retia Medical, LLC · Class II
Retia Medical — Retia Medical, LLC · Class II

Cleared under the same submission

K181372 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

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

Manufacturer

Manufacturer: Retia Medical, LLC

Sources (1)

FDA UDI 8784c849-5516-451d-88f2-661f3157bb27 35 fields · synced May 30, 2026