70105.2794

GUDID 04037691741543

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 04037691741543
• NIH Device Record Key: 60412e6f-6015-4a9d-8b6f-0b0d8e11d81e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HLS Set Advanced 7.0, Adult, BIOLINE Coating
• Catalog Number: 70105.2794
• 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
• 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
• 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
• 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
• 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
• 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
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691741543 [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: 2022-12-08
• Device Publish Date: 2015-11-12

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691645148 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for rail
• 04037691645155 - NA: 2024-12-11 CARDIOHELP Emergency Drive Holder for mast
• 04037691720791 - NA: 2024-12-11 CARDIOHELP Holder for mast
• 04037691002583 - NA: 2024-09-30
• 04037691349190 - BMU 40: 2024-09-30
• 04037691349206 - BMU 40: 2024-09-30
• 04037691349213 - BMU 40: 2024-09-30
• 04037691349220 - BMU 40: 2024-09-30