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510(k) Data Aggregation
K Number
K223168Device Name
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
Manufacturer
Medtronic Inc.
Date Cleared
2023-04-19
(190 days)
Product Code
QWF
Regulation Number
870.4100Why did this record match?
Product Code :
QWF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.
Device Description
The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.
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