70100.5668

GUDID 04037691128948

Venous Catheter, two-stage, complete reinforcement, Bullet tip, without connector

Maquet Cardiopulmonary AG

Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 04037691128948
• NIH Device Record Key: 2156235c-bd19-4ccd-8475-137d2a0862ab
• Commercial Distribution Discontinuation: 2020-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: Ven.Cath.,2-stage,reinf.,Bullet tip
• Catalog Number: 70100.5668
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com
• Phone: +49072229320
• Email: info.cp@maquet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04037691085098 [Primary]
GS1	04037691128948 [Package]; Contains: 04037691085098; Package: [10 Units]; Discontinued: 2020-01-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013944

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-10-24

Devices Manufactured by Maquet Cardiopulmonary AG

• 04037691075068 - VBT Venous Bubble Trap: 2023-06-02 Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the ve
• 04037691032528 - NA: 2023-06-02
• 04037691576640 - Quadrox-iD: 2022-12-13
• 04037691588285 - HLS Set: 2022-12-13
• 04037691741130 - NA: 2022-12-08
• 04037691741543 - NA: 2022-12-08
• 04037691773513 - NA: 2022-12-08
• 04037691009025 - NA: 2022-12-06