SOF-SENSOR ®

GUDID 20613994598404

SENSOR MMT-7002C 10PK BSA NREFR 21L

MEDTRONIC MINIMED, INC.

Percutaneous glucose monitoring system Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID20613994598404
NIH Device Record Key1dacc2ac-80f4-457f-8b06-288b2941f486
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOF-SENSOR ®
Version Model NumberMMT-7002C
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994598400 [Unit of Use]
GS120613994598404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, glucose, invasive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-10

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00763000910150 - MiniMed™ Mobile2024-03-18 SFTWR MMT-6102 AHCL APP 2.5 IOS
20763000837215 - Extended™ Reservoir 3.0mL2024-02-26 RSVR MMT-342G 5PK EW 3ML US
20763000837239 - Extended™ Reservoir2024-02-20 RSVR MMT-342G 5PK EW 3ML US
00763000837259 - Extended Reservoir™2024-02-20 RSVR MMT-342G 5PK EW 3ML US
00763000910082 - MiniMed™ 780G2024-02-12 PUMP MMT-1884L MM780G MG 6.21 A1.01 PRB

Trademark Results [SOF-SENSOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOF-SENSOR
SOF-SENSOR
78043010 2972580 Live/Registered
MEDTRONIC MINIMED, INC.
2001-01-12

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