GUDID 00613994757616

SENSOR LS100 LEVEL DETECTOR LOW PROF 12L

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID00613994757616
NIH Device Record Key8de14218-7417-49d4-8c56-8edf293c5af6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLS100
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Limitation of 700 hPa to 1063 hPa
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994757616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWAControl, pump speed, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-19

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