QUADROX-i 70105.5207

GUDID 04037691773414

Maquet Cardiopulmonary AG

Cardiotomy reservoir

• Primary Device ID: 04037691773414
• NIH Device Record Key: 456cffc8-ee04-4688-bc3d-c1bb3da78693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUADROX-i
• Version Model Number: Neonatal, filter, reservoir
• Catalog Number: 70105.5207
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04037691773414 [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

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• 04058863005805: QUADROX-i Small Adult HMO 50000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoi
• 04037692010013: Small Adult, reservoir, filter
• 04037692011362: Small Adult, reservoir
• 04037692009994: Adult, reservoir, filter
• 04037692009987: Adult, reservoir
• 04037692011379: Small Adult, Filter; BIOLINE Coating
• 04037692010532: Small Adult, BIOLINE
• 04037692010563: Small Adult. Filter
• 04037692010556: Small Adult
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• 04037692010471: Adult
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• 04037691782089: Adult
• 04037691780542: Pediatric, reservoir
• 04037691780481: Small Adult. Filter
• 04037691780139: Neonatal, reservoir
• 04037691775388: Pediatric, filter, reservoir
• 04037691773414: Neonatal, filter, reservoir
• 04037691770987: Pediatric, filter
• 04037691670171: Pediatric, diffusion, BIOLINE
• 04037691452982: Small Adult, BIOLINE