SENSOR LS100 LEVEL DETECTOR LOW PROF 12L Medical Device Identification

GUDID 00613994757616

SENSOR LS100 LEVEL DETECTOR LOW PROF 12L

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	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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