Select 3D® II

GUDID 00643169158955

CANN CB78524 SEL 3D II 24F 17L

MEDTRONIC, INC.

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

• Primary Device ID: 00643169158955
• NIH Device Record Key: ee1311f1-8c15-451f-96b2-e9ba4c82b18a
• Commercial Distribution Discontinuation: 2017-07-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Select 3D® II
• Version Model Number: CB78524
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: true
• 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

Device Dimensions

• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169158955 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-24

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