FDA.reportPublic FDA data

Guardian™ Sensor (3)

Primary DI
20763000516233
Brand
Guardian™ Sensor (3)
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7020MLA
Device description
SENSOR MMT-7020MLA GS3 5PK 2L US
Published
2021-06-03
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
P160007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160007000Guardian Connect systemMedtronic Minimed2018-03-08MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000516233PrimaryGS10
00763000516239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300051623320763000516233
00763000516239007630005162397630005162390763000516239

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system sensorA small, electronic device with micro-needle(s) intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
5
Lot or batch
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
00763000578848Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-11-26
00763000578794Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000578798Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
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
00763000002596Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2018-11-29