HL 20 701020745

GUDID 04037691261386

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04037691261386
• NIH Device Record Key: fcc7bf2d-39f9-4b34-a848-1d9adf0f5913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HL 20
• Version Model Number: CRM 20-118 Cross mast, 5-pump
• Catalog Number: 701020745
• 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	04037691261386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943803

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 [HL 20 ]

• 04037691762326: Extended Mast System
• 04037691585598: Side guard
• 04037691457659: Complete Holder 200mm Arm
• 04037691289939: CRM 20-117 Cross Mast,4-pump
• 04037691276717: Temperature box holder
• 04037691261386: CRM 20-118 Cross mast, 5-pump
• 04037691260129: VEM 20-119 Vertic Mast short