Cardiohelp 701033314

GUDID 04037691320786

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04037691320786
• NIH Device Record Key: fa6b6929-054e-4648-a3c4-87fff6fdeb81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiohelp
• Version Model Number: Mast adapter D33 H45
• Catalog Number: 701033314
• 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: false
• 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: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com
• Phone: +4972229320
• Email: info.cp@getinge.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691320786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102726

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: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [Cardiohelp]

• 04058863084336: CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARD
• 04037691682549: Mast adapter D30 H45
• 04037691320786: Mast adapter D33 H45
• 04037691260730: MTK 20-554 Medex LogiCal Transducer Holder