MAQUET HL-20 System 701020804

GUDID 04037691786544

The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.

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 Cardiopulmonary bypass system, roller type

• Primary Device ID: 04037691786544
• NIH Device Record Key: f48ae3c8-63d3-44e2-9df5-f0a6aac4ac5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAQUET HL-20 System
• Version Model Number: DTI 1/4"x1/16" (2 pcs)
• Catalog Number: 701020804
• 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
• Phone: +4972229320
• Email: info.cp@getinge.com

Device Dimensions

• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter
• Total Volume: 0.118 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691786544 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-01
• Device Publish Date: 2017-09-18

On-Brand Devices [MAQUET HL-20 System]

• 04037691786544: The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as an accessroy fo
• 04037691477251: The STI 1/2" x 1/16" (4 pcs) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy f
• 04037691477206: The STI 1/4" x 1/16" (4 pcs.) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy