GUDID 00613994258106

TAPE LST LEVEL DETECTOR MOUNT

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00613994258106
• NIH Device Record Key: 7c722863-fbb0-4d76-920d-2dd95a76436a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LST
• 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: 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: 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Atmospheric Limitation of 700 hPa to 1060 hPa
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994258106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070286

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-19

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