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PLEGIOX Heat Exchanger with Cardioplegia

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name
PLEGIOX Heat Exchanger with Cardioplegia FDA UDI
Generic Name
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
Device Name
The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed. FDA UDI
Model / Reference
CHX 30, Non-coated, Sterile FDA UDI
Description
The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed. FDA UDI

Identifiers

Catalog Number
70103.2522 FDA UDI
Primary DI / UDI-DI
04037691180038 FDA UDI
510(k) Number
K112360 FDA UDI
FDA Product Code
KFM FDA UDI
DTR FDA UDI
DTM FDA UDI
DTZ FDA UDI
GMDN Term
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4360 FDA UDI
870.4240 FDA UDI
870.4260 FDA UDI
870.4350 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 46.885 Liter FDA UDI
Weight — 0.35 Kilogram FDA UDI

PLEGIOX Heat Exchanger with Cardioplegia by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112360 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI e793bf94-7ec5-4c38-96ce-c4f82195db6a 38 fields · synced May 30, 2026