PLEGIOX Cardioplegia Heat Exchanger

Basic Information

• Brand Name: PLEGIOX Cardioplegia Heat Exchanger
• Primary DI: 04037691229591
• Version / Model: BO-CHX 30, SOFTLINE, Sterile
• Catalog Number: 70103.4981
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 5
• Public Version Date: 2024-09-30
• Public Version Status: Update
• Public Device Record Key: c137f443-d2ae-4ef6-bc98-e6f0a982d3af
• Distribution End Date: 2024-09-25

Device Description

PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	870.4350	2
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	870.4260	2
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11973	Cardiopulmonary bypass system heat exchanger, reusable	A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691229591	GS1
Package	04037691229584	GS1		8	Not in Commercial Distribution	2024-09-25

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112360	000