MAQUET HL-20 System

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name: MAQUET HL-20 System FDA UDI
Generic Name: Cardiopulmonary bypass system, roller type FDA UDI
Device Name: The STI 1/4" x 1/16" (4 pcs.) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung. FDA UDI
Model / Reference: STI 1/4" x 1/16" (4 pcs) FDA UDI
Description: The STI 1/4" x 1/16" (4 pcs.) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung. FDA UDI

Identifiers

Catalog Number: 701020798 FDA UDI
Primary DI / UDI-DI: 04037691477206 FDA UDI
510(k) Number: K943803 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Cardiopulmonary bypass system, roller type FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4220 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 0.02 Kilogram FDA UDI

Category: Cardiopulmonary bypass system, roller type

MAQUET HL-20 System by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system, roller type.

Variolock — LivaNova Deutschland GmbH · Class II
Venous Line Clamp — LivaNova Deutschland GmbH · Class II
SCP — LivaNova Deutschland GmbH · Class II
Accessories — LivaNova Deutschland GmbH · Class II
AVID TruCustom — AVID MEDICAL, INC. · Class II
S5 Roller Pump 150 — LivaNova Deutschland GmbH · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
S5 Shelf without AC Outlet Strip — LivaNova Deutschland GmbH · Class II

Cleared under the same submission

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: Maquet Cardiopulmonary AG

Sources (1)

FDA UDI c52fe5e0-1ad7-4b30-b62c-f1047fa21ccd 37 fields · synced Jun 6, 2026