Bio-Console®

GUDID 00763000135447

CONSOLE 560BCS1 CONTROL W/SAFETY MEE NR

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00763000135447
• NIH Device Record Key: d7b2f118-2d9c-4537-befb-c348fe09ebdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Console®
• Version Model Number: 560BCS1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000135447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080824

FDA Product Code

• DWA: Control, pump speed, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-26
• Device Publish Date: 2018-10-25

On-Brand Devices [Bio-Console®]

• 00613994450463: CONSOLE 560BCS1 CONTROLLER W/SAFETY BRD
• 00613994450456: CONSOLE E560BCS1 EVAL CONTROLLER
• 00613994450326: CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD
• 00613994450319: CONSOLE R560BCS1 REFURB CONTROLLER
• 00763000135447: CONSOLE 560BCS1 CONTROL W/SAFETY MEE NR
• 00763000236540: REFURB CONSOL R560BCS1 W/S BRD 7L NR EMC
• 00763000236533: EVAL CONSOLE E560BCS1 W/S BRD 7L NR EMC
• 00763000236526: CONSOLE 560BCS1 W/SAFETY BRD 7L NR EMC
• 00763000167325: CONSOLE 560BCS1 CONTROL W/SAFETY BRD MEE