70104.8595

GUDID 04037691572758

Maquet Cardiopulmonary AG

Cardiotomy reservoir

• Primary Device ID: 04037691572758
• NIH Device Record Key: 26e85659-5d08-4d26-85ba-59abd19058b7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Pediatric Venous Hardshell Reservoir
• Catalog Number: 70104.8595
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Pore Size: 64 Micrometer
• Total Volume: 1700 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691572758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141432

FDA Product Code

• DTP: Defoamer, 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: 2020-01-22
• Device Publish Date: 2015-10-24

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