FDA.reportPublic FDA data

mySentry™

Primary DI
00613994545503
Brand
mySentry™
Company
MEDTRONIC MINIMED, INC.
Model
MMT-9101NAR
Device description
MONITOR MMT-9101NAR MYSENTRY GLC EN RPL
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDSSensor, glucose, invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDSSensor, Glucose, InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980022075

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980022075CONTINUOUS GLUCOSE MONITORING SYSTEMMedtronic Minimed1999-06-15MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994545503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994545503006139945455036139945455030613994545503

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
849626338
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000578794Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000578798Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000516233Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
00763000516239Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
20763000455662Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455686Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455675Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455668Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455682Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455655Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
00763000455651Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
00763000348021TesterMEDTRONIC MINIMED, INC.MDS2021-03-28
00763000423124Paradigm® REAL-TimeMEDTRONIC MINIMED, INC.MDS2020-11-15
00763000423131Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.MDS2020-11-15
00763000388355Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-11-09
00763000388379Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-10-26
00763000408886Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-08-03
00763000408893Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-08-03
00763000381097Guardian™ Connect AppMEDTRONIC MINIMED, INC.MDS2020-08-02
00763000381103Guardian™ Connect AppMEDTRONIC MINIMED, INC.MDS2020-08-02
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2020-07-10
00763000399009Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-07-02
00763000398330Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-06-19
00763000341923One-press SerterMEDTRONIC MINIMED, INC.MDS2020-05-16
00763000285852Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2019-08-29
00763000179601Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-23
00763000179625Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22
20763000179629Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22