MAQUET CARDIOHELP 70107.1881

GUDID 04058863112176

CARDIOHELP Emergency Drive

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04058863112176
• NIH Device Record Key: fa63ea37-066f-45a1-8573-15e105929714
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAQUET CARDIOHELP
• Version Model Number: CARDIOHELP Emergency Drive (w/o holder)
• Catalog Number: 70107.1881
• 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: 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	04058863112176 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-26
• Device Publish Date: 2018-09-25

On-Brand Devices [MAQUET CARDIOHELP]

• 04058863112176: CARDIOHELP Emergency Drive
• 04037691816449: MAQUET CARDIOHELP Bubble Sensor BS 3/8x1/16-1/4x3/32 L1.7
• 04037691643526: CARDIOHELP Emergency Drive