MAQUET CARDIOHELP 70107.2780

GUDID 04058863074863

The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circul

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04058863074863
• NIH Device Record Key: aad2ac39-8aa0-4bc5-abfc-c48725cdc659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAQUET CARDIOHELP
• Version Model Number: CARDIOHELP-i
• Catalog Number: 70107.2780
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	04058863074863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133598

FDA Product Code

• DTQ: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-01

On-Brand Devices [MAQUET CARDIOHELP]

• 04058863074863: The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump bloo
• 04037691734941: CARDIOHELP Country Kit EnglUS
• 04037691456577: Base plate Holder HKH 8850. Ground Plate for Helicopter. An accessory of CARDIOHELP System.