PLEGIOX Cardioplegia Heat Exchanger 70103.4981

GUDID 04037691229591

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.

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 04037691229591
• NIH Device Record Key: c137f443-d2ae-4ef6-bc98-e6f0a982d3af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLEGIOX Cardioplegia Heat Exchanger
• Version Model Number: BO-CHX 30, SOFTLINE, Sterile
• Catalog Number: 70103.4981
• Company DUNS: 316153865
• Company Name: Maquet Cardiopulmonary AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49072229320
• Email: info.cp@maquet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691229584 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	04037691229591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112360

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-03-13

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691075068 - VBT Venous Bubble Trap: 2023-06-02 Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the ve
• 04037691032528 - NA: 2023-06-02
• 04037691576640 - Quadrox-iD: 2022-12-13
• 04037691588285 - HLS Set: 2022-12-13
• 04037691741130 - NA: 2022-12-08
• 04037691741543 - NA: 2022-12-08
• 04037691773513 - NA: 2022-12-08
• 04037691009025 - NA: 2022-12-06