QUADROX-iD 70104.1146

GUDID 04037691741161

QUADROX-iD Adult, without filter, SOFTLINE coating, non-sterilized, semi-finished Product.

Maquet Cardiopulmonary AG

Extracorporeal membrane oxygenator

• Primary Device ID: 04037691741161
• NIH Device Record Key: 5b71634e-0871-40c1-94a1-d62df13cc3fd
• Commercial Distribution Discontinuation: 2020-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QUADROX-iD
• Version Model Number: 01970111
• Catalog Number: 70104.1146
• 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

Device Dimensions

• Total Volume: 215 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691741161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132829

FDA Product Code

• DTR: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04037691741161]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-03
• Device Publish Date: 2017-11-16

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• 04037691741161: QUADROX-iD Adult, without filter, SOFTLINE coating, non-sterilized, semi-finished Product.
• 04037691739335: QUADROX-iD Adult, without filter, BIOLINE Coating, non-sterile, semi-finished product.
• 04058863299983: QUADROX-iD Pediatric with BIOLINE Coating
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