FDA.reportPublic FDA data

MiniMed Flex

Primary DI
00199150021031
Brand
MiniMed Flex
Company
MEDTRONIC MINIMED, INC.
Model
MMT-8070
Device description
HARGER MMT-8070 8XX FLEX REPL
Published
2026-05-24
Public version status
New
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
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
00199150021031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150021031001991500210311991500210310199150021031

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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
00199150077380MiniMed FlexMMT-80622026-05-25
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
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
00763000721350Simplera™MMT-84002025-07-08
00763000721367Simplera™MMT-84012025-07-08
00199150003686MiniMed™ 780GMMT-1884G2025-06-19
00763000960018MiniMed™ 780GMMT-18942025-06-19
00763000960025MiniMed™ 780GMMT-1894MD2025-06-19
00763000960049MiniMed™ 780GMMT-18842025-06-19
00763000956394Simplera Sync™MMT-5120B2025-06-01
20763000956404Simplera Sync™MMT-5120PA2025-06-01
20763000956411Simplera Sync™MMT-5120MA2025-06-01
00763000960032MiniMed™ 780GMMT-18842025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150077380MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-25
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
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
20385083000425Omnipod 5 PodInsulet CorporationQFG2025-12-04
00389152706474Pharmacy Kit, Starter Pack, Tandem T:slimTandem Diabetes Care, Inc.QFG2025-05-23
00389152708379Tandem t:slim AutoSoft XC 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
00389152523347Tandem Mobi Mobile ApplicationTandem Diabetes Care, Inc.QFG2025-04-22
00389152470641Tandem t:slim Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-03-14
00389152470740t:slim Mobile Application, iOSTandem Diabetes Care, Inc.QFG2025-03-14
00389152493671Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+Tandem Diabetes Care, Inc.QFG2025-03-13
00389152407012t:slim X2 Insulin Pump with Control-IQ+ TechnologyTandem Diabetes Care, Inc.QFG2025-01-17
00389152407111t:slim X2 Insulin Pump with Control-IQ+ TechnologyTandem Diabetes Care, Inc.QFG2025-01-17
00389152407210t:slim X2 Insulin Pump with Control-IQ+ TechnologyTandem Diabetes Care, Inc.QFG2025-01-17
00389152407319t:slim X2 Insulin Pump with Control-IQ+ TechnologyTandem Diabetes Care, Inc.QFG2025-01-17
00389152559575Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2024-12-23
00389152559773Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2024-12-23
00389152559971Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2024-12-23
00850050080138iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Beta Bionics, Inc.QFG2024-11-13
00850050080213iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) Beta Bionics, Inc.QFG2024-11-13
00850050080220iLet Insulin Infusion Kit – Contact Detach (23”, 6mm) 15-Pack (Pharmacy Kit)Beta Bionics, Inc.QFG2024-11-13