Flow Measurement

FDA UDI

Class II (US FDA UDI)

by LivaNova Deutschland GmbH

Identity

Trade Name: Flow Measurement FDA UDI
Generic Name: Cardiopulmonary bypass system, roller type FDA UDI
Model / Reference: Sensor Stöckert 3/8" x 3/32" FDA UDI

Identifiers

Primary DI / UDI-DI: 04033817901501 FDA UDI
510(k) Number: K112225 FDA UDI
FDA Product Code: DWA FDA UDI
GMDN Term: Cardiopulmonary bypass system, roller type FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4380 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: Cardiopulmonary bypass system, roller type

Flow Measurement by LivaNova Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system, roller type.

HL 20 — Maquet Cardiopulmonary AG · Class II
AVID TruCustom — AVID MEDICAL, INC. · Class II
ROTAFLOW — Maquet Cardiopulmonary AG · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
AVID TruCustom — AVID MEDICAL, INC. · Class II
MAQUET HL-20 System — Maquet Cardiopulmonary AG · Class II
MAQUET HL-20 System — Maquet Cardiopulmonary AG · Class II

Cleared under the same submission

K112225 also covers:

CP5 — LivaNova Deutschland GmbH
CP5 — LivaNova Deutschland GmbH
CP5 — LivaNova Deutschland GmbH
CP5 — LivaNova Deutschland GmbH
Flow Measurement — LivaNova Deutschland GmbH

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: LivaNova Deutschland GmbH

Sources (1)

FDA UDI a6d1837e-cff2-4c75-9b4e-405eef4e9234 33 fields · synced May 30, 2026