FDA.reportPublic FDA data

Sugar.IQ™

Primary DI
00763000086619
Brand
Sugar.IQ™
Company
MEDTRONIC MINIMED, INC.
Model
MMT-8100
Device description
SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
Published
2018-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHVContinuous glucose monitor retrospective data analysis software
PKUInsulin pump secondary display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1
PKUInsulin Pump Secondary DisplayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000086619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000086619007630000866197630000866190763000086619

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

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
Premarket exempt
true
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
B553202311OTC0WelldocWELLDOC, INC.PHV2026-03-09
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
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMEDTRONIC MINIMED, INC.PKU2025-09-26
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PKU2025-09-26
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
00763000984762CareLink™ ClinicMEDTRONIC MINIMED, INC.PHV2025-01-02
B553202057OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2024-12-27
00850050080169Bionic Circle App, iOSBeta Bionics, Inc.PKU2024-11-13
00850050080176Bionic Circle App, Android Beta Bionics, Inc.PKU2024-11-13
00763000968168MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000968175MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000943257MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000943264MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000791391CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2024-03-21
00763000910143MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000910150MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000867621MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
00763000867638MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
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
00763000521301MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-08-05