Transonic

FDA UDI

Class II (US FDA UDI)

by Transonic Systems Inc.

Identity

Trade Name: Transonic FDA UDI
Generic Name: Thermal-dilution cardiac output unit FDA UDI
Model / Reference: HCP01 FDA UDI

Identifiers

Primary DI / UDI-DI: 00877466000321 FDA UDI
510(k) Number: K080116 FDA UDI
FDA Product Code: DXG FDA UDI
GMDN Term: Thermal-dilution cardiac output unit 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Thermal-dilution cardiac output unit

Transonic by Transonic Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Thermal-dilution cardiac output unit.

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CO-SET+ — Edwards Lifesciences LLC · Class II
CO-SET+ — Edwards Lifesciences LLC · Class II
CO-SET+ — Edwards Lifesciences LLC · Class II
Injectate temperature sensor housing — Pulsion Medical Systems SE · Class II
SP5045 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II

Cleared under the same submission

K080116 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: Transonic Systems Inc.

Sources (1)

FDA UDI cc7361d5-c1ed-4201-9329-86442172b819 33 fields · synced May 29, 2026