GUDID 00613994757616

SENSOR LS100 LEVEL DETECTOR LOW PROF 12L

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00613994757616
• NIH Device Record Key: 8de14218-7417-49d4-8c56-8edf293c5af6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LS100
• 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

• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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 1063 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	00613994757616 [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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