Medtronic Guardian™ Link

GUDID 00643169283183

CHARGER MMT-7715 MLNK GST3 21L RPL

MEDTRONIC MINIMED, INC.

Percutaneous glucose monitoring system
Primary Device ID00643169283183
NIH Device Record Keyff0537bb-714d-4b40-ae28-870cbc5892d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedtronic Guardian™ Link
Version Model NumberMMT-7715
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169283183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, glucose, invasive

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 Date2016-09-23

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