QUADROX-i 70106.7970

GUDID 04058863018867

QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight

Maquet Cardiopulmonary AG

Cardiotomy reservoir

• Primary Device ID: 04058863018867
• NIH Device Record Key: 55f58c34-b4fe-4c8b-94b3-7525c752bc5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUADROX-i
• Version Model Number: Small Adult, reservoir, filter VKMO 51000-USA #SQU
• Catalog Number: 70106.7970
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058863018867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132166

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: 2017-02-15

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