FDA.reportPublic FDA data

MiniMed ® Connect

Primary DI
00643169873827
Brand
MiniMed ® Connect
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7000NAU
Device description
KIT MMT-7000NAU PRDGM XMTR CONN BT US
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00643169873827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169873827006431698738276431698738270643169873827

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronicA portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).

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
Storage Environment Temperature-4 Degrees Fahrenheit131 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
DM exempt
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