FDA.reportPublic FDA data

MiniMed Flex

Primary DI
00199150077380
Brand
MiniMed Flex
Company
MEDTRONIC MINIMED, INC.
Model
MMT-8062
Device description
PUMP MMT-8062 Flex FOTA SW1.2.0 US
Published
2026-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFGAlternate controller enabled insulin infusion pump

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253743000MiniMed Flex pumpMedtronic Minimed, Inc.2026-03-12QFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150077380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150077380001991500773801991500773800199150077380

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 Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
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
00613994951397iPro™2MMT-77472014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150021031MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-24
00763000848149MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00763000848156MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
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
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
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
10385083000411Omnipod 5 PodInsulet CorporationQFG2025-12-04
20385083000425Omnipod 5 PodInsulet CorporationQFG2025-12-04
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.QFG2025-11-08
00389152690940Tandem Mobi Mobile Application, iOSTandem Diabetes Care, Inc.QFG2025-10-06
00389152706474Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+Tandem Diabetes Care, Inc.QFG2025-05-23
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708379Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708973Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152709574Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152710174Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152480114Tandem Mobi, pump, Control-IQ 7.9Tandem Diabetes Care, Inc.QFG2025-04-25