FDA.reportPublic FDA data

MiniMed 780G Insulin Pump

Primary DI
00199150047055
Brand
MiniMed 780G Insulin Pump
Company
MEDTRONIC MINIMED, INC.
Model
MMT-1894MD
Device description
KIT MMT-1894MD 780G US GOV 6.62U A2.0X
Published
2025-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDCCalculator, drug dose
QFGAlternate controller enabled insulin infusion pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251032000MiniMed 780G insulin pumpMedtronic Minimed, Inc.2025-07-01QFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150047055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150047055001991500470551991500470550199150047055

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.

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
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150084036MiniMed Flex Starter KitMEDTRONIC, INC.QFG2026-07-19
00199150084043MiniMed Flex Starter KitMEDTRONIC, INC.QFG2026-07-19
00199150084050MiniMed Extended Supply KitMEDTRONIC, INC.QFG2026-07-19
00199150084067MiniMed Extended Supply KitMEDTRONIC, INC.QFG2026-07-19
00199150001231App ManagerMEDTRONIC MINIMED, INC.NDC2026-06-18
00199150038978MiniMed GoMEDTRONIC MINIMED, INC.NDC2026-06-14
00199150038985MiniMed GoMEDTRONIC MINIMED, INC.NDC2026-06-14
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150077380MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-25
00199150021031MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-24
00763000848149MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00763000848156MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QFG2026-03-11
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00860015223906UpDocUpDoc Inc.NDC2026-01-13
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152852379Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152852973Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152853772Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854373Tandem Mobi TruSteel KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854977Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152855578Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856179Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10