PLEGIOX Heat Exchanger with Cardioplegia 70103.2522

GUDID 04037691180038

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.

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID04037691180038
NIH Device Record Keye793bf94-7ec5-4c38-96ce-c4f82195db6a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLEGIOX Heat Exchanger with Cardioplegia
Version Model NumberCHX 30, Non-coated, Sterile
Catalog Number70103.2522
Company DUNS316153865
Company NameMaquet Cardiopulmonary AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com

Device Dimensions

Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram
Total Volume46.885 Liter
Weight0.35 Kilogram

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691180038 [Primary]
GS104058863052267 [Package]
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2017-05-02

Devices Manufactured by Maquet Cardiopulmonary AG

04037691002583 - NA2024-09-30
04037691349190 - BMU 402024-09-30
04037691349206 - BMU 402024-09-30
04037691349213 - BMU 402024-09-30
04037691349220 - BMU 402024-09-30
04037691349237 - BMU 402024-09-30
04037691349244 - BMU 402024-09-30
04037691456584 - NA2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation.
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