70105.2786

GUDID 04037691741130

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 04037691741130
• NIH Device Record Key: 22637bd1-6049-4faa-8185-8e51e0e13490
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HIT Set Advanced 7.0, Adult, SOFTLINE Coating
• Catalog Number: 70105.2786
• 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: false
• 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
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com

Device Dimensions

• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691741130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112360

FDA Product Code

• DTR: HEAT-EXCHANGER, 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: 2022-12-08
• Device Publish Date: 2015-11-12

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
• 04037691741130 - NA: 2022-12-08
• 04037691741543 - NA: 2022-12-08
• 04037691773513 - NA: 2022-12-08
• 04037691009025 - NA: 2022-12-06