BioMedicus™

GUDID 00643169025769

CANNULA 96570-119 BIO-MEDICUS 19FR EA

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, femoral

• Primary Device ID: 00643169025769
• NIH Device Record Key: 0f6a4f54-da2a-4780-b590-1a3f0d9a23ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioMedicus™
• Version Model Number: 96570-119
• 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: 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 19 French
• Catheter Gauge: 19 French
• Catheter Gauge: 19 French
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French
• Length: 31.8 Centimeter
• Catheter Gauge: 19 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169025769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142673

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: 2019-04-29
• Device Publish Date: 2016-04-16

On-Brand Devices [BioMedicus™]

• 00643169026001: CANNULA 96670-115 BIO-MEDICUS 15FR EA
• 00643169025998: CANNULA 96670-117 BIO-MEDICUS 17FR EA
• 00643169025981: CANNULA 96670-119 BIO-MEDICUS 19FR EA
• 00643169025974: CANNULA 96670-121 BIO-MEDICUS 21FR EA
• 00643169025950: CANNULA 96670-125 BIO-MEDICUS 25FR EA
• 00643169025943: CANNULA 96670-127 BIO-MEDICUS 27FR EA
• 00643169025936: CANNULA 96670-129 BIO-MEDICUS 29FR EA
• 00643169025776: CANNULA 96570-117 BIO-MEDICUS 17FR EA
• 00643169025769: CANNULA 96570-119 BIO-MEDICUS 19FR EA
• 00643169025752: CANNULA 96570-121 BIO-MEDICUS 21FR EA
• 00643169025745: CANNULA 96570-123 BIO-MEDICUS 23FR EA
• 00643169025738: CANNULA 96570-125 BIO-MEDICUS 25FR EA