MAQUET HL-20 System 701020800

GUDID 04037691477251

The STI 1/2" x 1/16" (4 pcs) is a Single 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

• Primary Device ID: 04037691477251
• NIH Device Record Key: 4e377577-e0de-4ca3-a194-17c1703ba802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAQUET HL-20 System
• Version Model Number: STI 1/2" x 1/16" (4 pcs)
• Catalog Number: 701020800
• 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

• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram
• Weight: 0.16 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691477251 [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