FDA.reportPublic FDA data

CareLink™ Clinic

Primary DI
00763000984762
Brand
CareLink™ Clinic
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7350
Device description
PRODUCT SOFTWARE MMT-7350 PROWEB 4.1A
Published
2025-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHVContinuous glucose monitor retrospective data analysis software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000984762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000984762007630009847627630009847620763000984762

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150001231App ManagerMMT-8097M2026-06-18
00199150038978MiniMed GoMMT-86002026-06-14
00199150038985MiniMed GoMMT-86012026-06-14
20763000336985Guardian™ Sensor (3)MMT-7020LA2020-10-12
20763000337005Guardian™ Sensor (3)MMT-7020A2020-07-10
20763000358444Guardian™ Sensor (3)MMT-7020PLA2020-10-31
20763000455655Guardian™ Sensor (3)MMT-7020GA2021-04-04
20763000455662Guardian™ Sensor (3)MMT-7020A2021-04-05
20763000455686Guardian™ Sensor (3)MMT-7020PLA2021-04-05
20763000497181Extended ReservoirMMT-3422022-09-09
20763000516233Guardian™ Sensor (3)MMT-7020MLA2021-06-03
20763000565026Simplera™ SensorMMT-5100JA2025-03-17
20763000565040Medtronic Simplera™ SensorMMT-5101N2025-03-17
20763000578804Guardian™ Sensor (3)MMT-7020LA2023-03-27
20763000829579Simplera™ SensorMMT-5100JPA2025-03-17
20763000829654Simplera™ SensorMMT-5101PN2025-03-17
20763000956381Simplera Sync™MMT-5120A2025-06-01
70643169771481MiniMed™ ReservoirMMT-332A2018-05-31
00643169705920Sil-serter™MMT-3852022-09-17
00643169771413MiniMed ReservoirMMT-326A2016-10-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003222331Center Health PHVCENTER HEALTH INCORPORATEDPHV2026-06-08
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B553202312OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202313OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202406OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-12-09
10385083000152Omnipod Discover Insulet CorporationPHV2025-12-04
B553202301OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202302OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202303OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202257OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-05-29
00763000984755CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2025-01-02
B553202057OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2024-12-27
00850018992435Sugarmate, iOS Mobile ApplicationSugarmate, LLCPHV2023-09-06
00850018992602Sugarmate, Mac Glance ApplicationSugarmate, LLCPHV2023-09-06
00850018992619Sugarmate, Web ApplicationSugarmate, LLCPHV2023-09-06
00850018992626Sugarmate, Alexa Skill ApplicationSugarmate, LLCPHV2023-09-06
00850003506517Bigfoot Unity ReportBigfoot Biomedical, Inc.PHV2023-07-12
00389152106113Tandem SourceTandem Diabetes Care, Inc.PHV2023-06-20
07290017735023endo.digitalDREAMED DIABETES LTDPHV2022-09-20
00817491023506Eversense DMSSENSEONICS, INCORPORATEDPHV2022-03-10
00817491023513Eversense DMS ProSENSEONICS, INCORPORATEDPHV2022-03-10
00357599826000LibreView GovernmentABBOTT DIABETES CARE INCPHV2021-07-15
00357599823009LibreViewABBOTT DIABETES CARE INCPHV2021-05-21
00763000424121CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2021-03-07
00763000424138CareLink™MEDTRONIC MINIMED, INC.PHV2021-03-07
00855093008033Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008040Cornerstones4Care® Powered by Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008026Glooko Web ApplicationGLOOKO, INC.PHV2021-02-16
00860000249515Onduo VERILY LIFE SCIENCES LLCPHV2020-08-25
00860000249522OnduoVERILY LIFE SCIENCES LLCPHV2020-08-25