FDA.reportPublic FDA data

MiniMed Connect

Primary DI
00643169631373
Brand
MiniMed Connect
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7000NA
Device description
KIT MMT-7000NA PRDGM XMTR CONN BT US
Published
2016-09-23
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
PKUInsulin pump secondary display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKUInsulin Pump Secondary DisplayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151236000MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)Medtronic Minimed, Inc.2015-05-19PJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169631373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169631373006431696313736431696313730643169631373

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous glucose monitoring systemAn assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

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
Kit
true
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
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMEDTRONIC MINIMED, INC.PKU2025-09-26
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PKU2025-09-26
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
00763000521301MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-08-05
00763000827786MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827793MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827298CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000827304CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000432652CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2022-06-25
00763000432645CareLink ™ConnectMEDTRONIC MINIMED, INC.PKU2022-06-24
00763000480646CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480653CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480660MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
00763000480677MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
10385081120265Omnipod (Dash) Display App.Insulet CorporationPKU2021-02-20
10385081120272Omnipod (Dash) View APPInsulet CorporationPKU2021-02-20
00763000416676MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000416669MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437794CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437787CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-05