FDA.reportPublic FDA data

MiniMed™ 770G

Primary DI
00763000545604
Brand
MiniMed™ 770G
Company
MEDTRONIC, INC.
Model
MMT-1890
Device description
KIT MMT-1890 MM770G V5.3A A1.01 BC
Published
2022-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZPAutomated insulin dosing device system, single hormonal control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZPAutomated Insulin Dosing Device System, Single Hormonal ControlUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160017076
P160017113

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160017076MiniMed 670G SystemMedtronic Minimed, Inc.2016-09-28OZP
P160017113MiniMed 670G SystemMedtronic Minimed, Inc.2016-09-28OZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000545604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000545604007630005456047630005456040763000545604

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithmA portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078351377
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150003686MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960018MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960025MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960049MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
20763000956381Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956400Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956417Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956394Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956404Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956411Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000960032MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956387Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000926106MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000926113MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000924089MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924096MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924102MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924119MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000910082MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-02-03
00763000865665MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2023-10-01
00365702702882ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
00365702702417ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
10365702702889ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
00365702702479ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00365702702530ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702476ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702537ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00763000859206One-press SerterMEDTRONIC MINIMED, INC.OZP2023-08-27