MC2™

GUDID 00763000193058

CANN CB91236C MC2 36/46F 17L

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, venous

• Primary Device ID: 00763000193058
• NIH Device Record Key: ebb4f4e5-9544-456f-b5fc-f25487f71c5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC2™
• Version Model Number: CB91236C
• 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
• 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: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French
• Catheter Gauge: 36 French
• Catheter Gauge: 46 French

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000193058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140165

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: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [MC2™]

• 00643169696952: CANNULA CB91329C MC2 VEN 29/29F CON 17
• 00643169696945: CANN CB91329 MC2 29/29FR 17L
• 00643169696938: CANN CB91265C MC2 36/46FR CON
• 00643169696921: CANN CB91265 MC2 VEN 36/46FR
• 00643169696914: CANN CB91263C MC2 OV 32/40F 17
• 00643169696907: CANN CB91263 MC2 OVAL 32/40F
• 00643169696891: CANNULA CB91251C MC2 VEN 36/51F CON 17
• 00643169696884: CANNULA CB91246C MC2 VEN 34/46F CON 17
• 00643169696877: CANN CB91246 MC2 34/46FR 17L
• 00643169696860: CANNULA CB91240C MC2 VEN 32/40F CON 17
• 00643169696853: CANN CB91240 MC2 32/40FR 17L
• 00643169696846: CANN CB91236C MC2 36/46F 17L
• 00643169696839: CANN CB91228C MC2 28/36FR 17L
• 00643169696822: CANN CB91228 MC2 28/36FR 17L
• 00763000193157: CANNULA CB91329C MC2 VEN 29/29F CON 17
• 00763000193140: CANN CB91329 MC2 29/29FR 17L
• 00763000193133: CANN CB91265C MC2 36/46FR CON
• 00763000193126: CANN CB91265 MC2 VEN 36/46FR
• 00763000193119: CANN CB91263C MC2 OV 32/40F 17
• 00763000193102: CANN CB91263 MC2 OVAL 32/40F
• 00763000193096: CANNULA CB91246C MC2 VEN 34/46F CON 17
• 00763000193089: CANN CB91246 MC2 34/46FR 17L
• 00763000193072: CANNULA CB91240C MC2 VEN 32/40F CON 17
• 00763000193065: CANN CB91240 MC2 32/40FR 17L
• 00763000193058: CANN CB91236C MC2 36/46F 17L
• 00763000193041: CANN CB91228C MC2 28/36FR 17L
• 00763000193034: CANN CB91228 MC2 28/36FR 17L