SELECT 3D® II

GUDID 00763000946869

CANNULA 78420 SELECT 3D II 20FR 20PK 17L

MEDTRONIC, INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

• Primary Device ID: 00763000946869
• NIH Device Record Key: ad22aaaf-9305-45b3-beee-c749dd1b2e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELECT 3D® II
• Version Model Number: 78420
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 20
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000946869 [Unit of Use]
GS1	20763000946863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043179

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-12
• Device Publish Date: 2024-08-03

On-Brand Devices [SELECT 3D® II]

• 00643169159235: CANN CB78422 SEL 3D II 22F 17L
• 00643169158955: CANN CB78524 SEL 3D II 24F 17L
• 00643169158948: CANN CB78522 SEL 3D II 22F 17L
• 00643169158924: CANN CB78424 SEL 3D II 24F 17L
• 20643169486274: CANNULA 78422 SELECT 3D II 22FR 20PK 17L
• 20643169486267: CANNULA 78420 SELECT 3D II 20FR 20PK 17L
• 20613994878971: CANNULA 78420 SELECT 3D II 20FR 20PK 17L
• 20613994878964: CANNULA 78422 SELECT 3D II 22FR 20PK 17L
• 20613994878957: CANNULA 78424 SELECT 3D II 24FR 20PK 17L
• 20613994878940: CANNULA 78520 SELECT 3D II 20FR 20PK 17L
• 20613994878933: CANNULA 78522 SELECT 3D II 22FR 20PK 10L
• 20613994878926: CANNULA 78524 SELECT 3D II 24FR 20PK 10L
• 00763000946869: CANNULA 78420 SELECT 3D II 20FR 20PK 17L