Cardiohelp 701033314

GUDID 04037691320786

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type 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