FDA Registration Active 🇺🇸 United States

MEDTRONIC MINIMED

Reg #: 2032227 · FEI: 3003166194 · Expires 2026
Products
24
Proprietary Names
321
Establishment Types
4
Classifications
24

Registration Details

Registration Name
MEDTRONIC MINIMED
Registration Number
2032227
FEI Number
3003166194
Status
Active
Expiry Year
2026
Initial Importer
No
Address
18000 Devonshire St
City
NORTHRIDGE
State
CA
ZIP
91325
Country
US

Regulatory Submissions

510(k) Number
K251032
PMA Number
P120010

Owner / Operator

Firm Name
Medtronic
Operator Number
10094334
Address
18000 Devonshire Street
City
Northridge
State
CA
Postal Code
91325
Country
US

Products

Device Name Product Code
Sensor, Glucose, Invasive MDS
Automated Insulin Dosing , Threshold Suspend OZO
Alternate Controller Enabled Insulin Infusion Pump QFG
Calculator, Drug Dose NDC
Insulin Pump Secondary Display PKU
Continuous Glucose Monitor Secondary Display PJT
Set, Administration, Intravascular FPA
Syringe, Piston FMF
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor OYC
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System SFI
Introducer, Syringe Needle KZH
Medical Device Data System OUG
Tubing, Fluid Delivery FPK
Pump, Infusion FRN
Automated Insulin Dosing Device System, Single Hormonal Control OZP
Accessories, Pump, Infusion MRZ
Pump, Infusion, Insulin LZG
Sensor, Glucose, Invasive, Non-Adjunctive PQF
Interoperable Automated Glycemic Controller, Insulin Suspend QJS
Interoperable Automated Glycemic Controller QJI
Continuous Glucose Monitor Retrospective Data Analysis Software PHV
Glucose Oxidase, Glucose CGA
Tape And Bandage, Adhesive KGX
Pump, Infusion, Implanted, Programmable LKK

Proprietary Names

MMT-7726 Water Tight Tester (Plug), Replacement MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) MMT-7725 MiniLink Real-Time Transmitter Starter Kit (MMT-7703, 7705, 7706, 7510) MMT-751 MiniMed 530G Insulin Pump 3ml MMT-7715 Charger, Replacement (Grey) MMT-7735 MiniLink REAL-Time Transmitter MMT-7706 MiniLink Tester Plug, Replacement MMT-7008 Enlite Sensor MMT-7510 ENLITE Serter MMT-551 MiniMed 530G Pump 1.8ml MMT-7512 One-Press Serter MMT-7703 MiniLink REAL-Time Transmitter, Replacement (GST1) MMT-7774 MiniLink Real-Time Transmitter Starter Kit (GST1E) MiniMed Extended Supply Kit MMT-1884 MiniMed 780G insulin pump MiniMed Extended Supply Kit (MMT-445C) MiniMed Extended Supply Kit (MMT-445B) MMT-6114 CareLink Clinical App iOS MMT-7000NAU MiniMed Connect System MMT-7000 MiniMed Connect kit MMT-7019 MiniMed Connect USB Charger MMT-7018 MiniMed Connect uploader MMT-7021 MiniMed Connect App MMT-7333 CareLink Connect (CareLink Personal) MMT-7001 MiniMed Connect app MMT-6102 MiniMed Mobile iOS MMT-6101 MiniMed Mobile Android MMT-6111 CareLink Connect Android MMT-6104 MiniMed Clinical App iOS MMT-6103 MiniMed Clinical App Android MMT-6112 CareLink Connect iOS MMT-6113 CareLink Clinical App Android MMT-391T MiniMed Quick-set MMT-393T MiniMed Quick-set MMT-390T MiniMed Quick-set MMT-392T MiniMed Quick-set MMT-105NNBL InPen™ smart insulin pen MMT-105ELBL InPen™ smart insulin pen MMT-105NNGY InPen™ smart insulin pen MMT-105ELGY InPen™ smart insulin pen MMT-105NNPK InPen™ smart insulin pen MMT-105ELPK InPen™ smart insulin pen MMT-723 Paradigm Real-Time Revel Insulin Pump 3ml MMT-7703 MiniLink REAL-Time Transmitter MMT-523 Paradigm Real-Time Revel Insulin Pump 1.8m MMT-7510 Enlite Serter MiniMed 780G insulin pump MMT-8600 MiniMed GO App iOS MMT-8601 MiniMed GO App Android MMT-8097 App Manager MMT-7841 Guardian 4 Transmitter MMT-5120 Simplera Sync sensor MMT-7040 Guardian Sensor 4 MMT-385 Sil-serter MMT-394T MiniMed Quick-set MMT-399T MiniMed Quick-set MMT-387T MiniMed Quick-set MMT-396T MiniMed Quick-set MMT-398T MiniMed Quick-set MMT-397T MiniMed Quick-set MMT-386T MiniMed Quick-set MMT-6122 Updater App (iOS) MMT-7305 CareLink USB MMT-6121 Updater App (Android) MMT-7306 CareLink USB MMT-383T MiniMed Silhouette MMT-382T MiniMed Silhouette MMT-381T MiniMed Silhouette MMT-384T MiniMed Silhouette MMT-368T MiniMed Silhouette MMT-378T MiniMed Silhouette MMT-377T MiniMed Silhouette MMT-305PS MiniMed Quick-Serter MMT-305QS MiniMed Quick-Serter MMT-103AT MiniMed Reservoir MMT-103A MiniMed Reservoir MMT-7020 Enlite 3 Sensor 5pk MMT-7512 One-press Serter MMT-7811 Guardian Link 3 Transmitter (GST3C) MMT-1760 MiniMed 670G Insulin Pump Kit MMT-7810 Guardian Link 3 Transmitter Kit (GST3C) MMT-7736 Tester 2pk MMT-1780 MiniMed 670G Insulin Pump MMT-7911NA Guardian Link (3) Transmitter (GST5C) MMT-1880 MiniMed 770G Insulin Pump MMT-7910NA Guardian Link (3) Transmitter Kit (GST5C) MMT-1890 MiniMed 770G Insulin Pump Kit MG/DL MMT-1884 MiniMed 780G Insulin Pump MMT-1884L MiniMed 780G Insulin Pump MMT-7840 Guardian 4 Transmitter Kit (GST5G) MMT-1894 MiniMed 780G Insulin Pump Kit MMT-373T MiniMed Silhouette MMT-371T MiniMed Silhouette MMT-1851 MiniMed 700 Kit 5.3P MMOL MMT-1800L MiniMed 700 Pump V5.3N BLE MG MMT-1801L MiniMed 700 Pump V5.3P BLE MMOL MMT-1800 MiniMed 700 Pump V5.3N BLE MG MMT-1801 MiniMed 700 Pump V5.3P BLE MMOL MMT-1850 MiniMed 700 Kit 5.3N MG MMT-242 MiniMed Mio Advance MMT-242A MiniMed Mio Advance MMT-100 MiniMed i-Port Advance MMT-5001B32 MiniMed Duo MMT-906A MiniMed Mio 30 MMT-5011A23 MiniMed Duo MMT-101T MiniMed i-Port Advance MMT-5001B18 MiniMed Duo MMT-442A MiniMed Extended Infusion Set MMT-906 MiniMed Mio 30 MMT-5001A32 MiniMed Duo MMT-5011B23 MiniMed Duo MMT-5011B18 MiniMed Duo MMT-244A MiniMed Mio Advance MMT-243A MiniMed Mio Advance MMT-440A MiniMed Extended Infusion Set MMT-5001A23 MiniMed Duo MMT-247 MiniMed Mio Advance MMT-443A MiniMed Extended Infusion Set MMT-5011B32 MiniMed Duo MMT-5001B43 MiniMed Duo MMT-905 MiniMed Mio 30 MMT-5011A32 MiniMed Duo MMT-905A MiniMed Mio 30 MMT-432A MiniMed Extended Infusion Set MMT-5001B23 MiniMed Duo MMT-100T MiniMed i-Port Advance MMT-431A MiniMed Extended Infusion Set MMT-5011B43 MiniMed Duo MMT-101 MiniMed i-Port Advance MMT-5011A18 MiniMed Duo MMT-5011A43 MiniMed Duo MMT-430A MiniMed Extended Infusion Set MMT-441A MiniMed Extended Infusion Set MMT-433A MiniMed Extended Infusion Set MMT-5001A18 MiniMed Duo MMT-5001A43 MiniMed Duo MMT-213A MiniMed Mio Advance MMT-8060 InPen™ app for iOS MMT-8061 InPen™ app for Android MMT-1755 MiniMed 630G System with SmartGuard™ Pump Kit MMT-7763 Guardian Link Transmitter MMT-7777 Guardian Link Transmitter Kit MMT-332A MiniMed Reservoir MMT-1715 MiniMed 630G System with SmartGuard™ Pump MMT-7726 Watertight Tester MMT-365 Polyfin QR with wings MMT-366 Polyfin QR with wings MMT-312S Paradigm Polyfin QR MMT-395 Quick-serter MMT-7304 ComLink MMT-7080C3 Envision Sensor MMT-7781C1, MMT-7781C2, MMT-7781D1, MT-7781D2 Envision Recorder MMT-7080D3 Envision Sensor MMT-7821EE Guardian Connect Transmitter CSS7201 Guardian Connect App Android Platform MMT-7820WE Guardian Connect CSS73 Guardian REAL-Time Continuous Glucose Monitoring System MMT-7763A Guardian Link Transmitter CSS7200 Guardian Connect App iOS Platform MMT-7513C One Press Serter MMT-7772 Guardian Link Transmitter System MMT-7715 Charger MMT-7820EE - Guardian Connect MMT-7730 Guardian 2 Link Transmitter System MMT-7772A Guardian Link Transmitter System MMT-7775 Guardian 2 Link Transmitter System MMT-7080C1 Envision Sensor MMT-7080D1 Envision Sensor MMT-7782 Envision Pro Mobile Application MMT-7738 Guardian 2 Link Transmitter MMT-7820NE Guardian Connect MMT-7821NE Guardian Connect Transmitter MMT-7080C2 Envision Sensor MMT-7731 Guardian 2 Link Transmitter MMT-7821WE Guardian Connect Transmitter MMT-7080D2 Envision Sensor MEDTRONIC MINIMED INFUSION PUMP MMT-369 MiniMed Silhouette MMT-370 MiniMed Silhouette MMT-332AT MiniMed Reservoir MMT-300 Sof-serter MMT-342 Extended Reservoir MMT-7330 ParadigmPAL MMT-7741 iPro2 MMT-7745 iPro2 MMT-7744 iPro2 Cleaning Plugs MMT-7736L Tester 2pk MMT-7020MLA Guardian Sensor (3) 5pk CSS7200 Guardian Connect App MMT-5120C Simplera Sync MMT-5101PN Simplera Sensor Kit Pharmacy 5PK MMT-5100JB Simplera Sensor 1PK MMT-8401 Simplera App Android MMT-5100JD Simplera Sensor 1PK MMT-8400 Simplera App iOS MMT-7821L Guardian Connect Transmitter MMT-5100JC Simplera Sensor 5PK MMT-5100JPA Simplera Sensor Pharmacy 5PK MMT-5100JA Simplera Sensor 5PK MMT-5101W Simplera System Sensor Starter Kit MMT-5101N Simplera Sensor Kit 5PK MMT-1895WW MiniMed 780G Pump Kit (mmol/L) MMT-7040QC Guardian 4 Sensor Lockout, 5 pack MMT-1886L MiniMed 780G Pump (mg/dL) MMT-7040QD Guardian 4 Sensor Lockout, 1 pack MMT-1885L MiniMed 780G Pump (mmol/L) MMT-1882 MiniMed 770G Insulin Pump MG/DL MMT-7040C Guardian 4 Sensor, 5 pack MMT-1896WW MiniMed 780G Pump Kit (mg/dL) MMT-7040D Guardian 4 Sensor, 1 pack MMT-1891 MiniMed 770G Insulin Pump Kit MMOL MMT-1881 MiniMed 770G Insulin Pump MMOL MMT-1892 MiniMed 770G Insulin Pump Kit MG/DL MMT-7920 Guardian 4 App System Kit MiniMed App MMT-8098 (iOS), MMT-8099 (Android) App Manager SmartGuard Technology; Predictive Low Glucose Technology iAGC Indication Expantion MMT-965T MiniMed Mio MMT-941T MiniMed Mio MMT-945T MiniMed Mio MMT-925T MiniMed Mio MMT-923T MiniMed Mio MMT-943T MiniMed Mio MMT-975T MiniMed Mio MMT-921T MiniMed Mio MMT-7340 CareLink iPro MMT-7334 CareLink Clinical MMT-7333 CareLink Personal MMT-7350 Carelink Software (Clinic) MMT-7333WW CareLink Personal Software MMT-7333 CareLink Personal Therapy Management Software for Diabetes MMT-7311 SOLUTIONS MMT-7315 GUARDIAN SOLUTIONS SOFTWARE MMT-9102 MYSENTRY OUTPOST MMT-7708 CGMS iPro Continuous Glucose Recorder MMT-7008 ENLITE GLUCOSE SENSOR MMT-7400 MiniMed Test Plug MMT-7102 Continuous Glucose Monitor MMT-7334 Medtronic CareLink MMT-7203 MiniMed Cable MMT-751 MINIMED 530G INSULIN PUMPS MMT-523k Paradigm REAL-Time Revel Insulin Pump MMT-753 PARADIGM REAL-TIME REVEL INSULIN PUMPS MMT-722 PARADIGM REAL-time Pump MMT-7712 CGMS iPro Wand MMT-7319 Solutions Software For CGMS iPro CONTINUOUS GLUCOSE RECORDER MMT-551 MINIMED 530G INSULIN PUMPS MMT-723k Paradigm REAL-Time Revel Insulin Pump MMT-7301 COM-STATION CSS72 Guardian REAL-Time Continuous Glucose Monitoring System CSS7100 GUARDIAN REAL-TIME MONITOR MMT-753K PARADIGM REAL-TIME REVEL INSULIN PUMPS MMT-9101 MYSENTRY MONITOR MMT-522 PARADIGM REAL-time Pump MMT-722k PARADIGM REAL-time Pump MMT-522k PARADIGM REAL-time Pump MMT-523 Paradigm REAL-Time Revel Insulin Pump MMT-7310 CGMS Com-Station Software MMT-7709 iPro Digital Recorder MMT-7707 MiniLink REAL-Time TRANSMITTER MMT-9100 MYSENTRY SYSTEM CSS7100k GUARDIAN REAL-TIME MONITOR MiniMed Flex Pump (MMT-8062) MiniMed Flex Starter Kit (MMT-8076C) MiniMed Flex Charger (MMT-8070) MiniMed Flex Pump Kit (MMT-8072) MiniMed Flex Starter Kit (MMT-8076B) MMT-326A MiniMed Reservoir MMT-326AT MiniMed Reservoir MMT-503 MiniMed Paradigm Insulin Pump, Model 511 MMT-712E PARADIGM Insulin Pump MMT-511 PARADIGM Insulin Pump MMT-7015 Oval Tape MMT-643NA Tape Kit MMT-172 Sof-set Adhesive Patch MMT-500 Remote Control MMT-508 MiniMed 508 MMT-3160 Personal Pump Communicator MMT-4027 Infusion Catheter MMT-2007 Implantable Insulin Pump MMT-4024 Infusion Catheter MMT- 4102 Refill Needle MMT-4105 Refill Kit MMT-7305 Medtronic MiniMed CareLink USB Connector Predictive Low Glucose technology SmartGuard technology MMT-1712 MiniMed 640G Insulin Pump MMT-1510 MiniMed 620G Pump MMT-1512 MiniMed 640G Insulin Pump MMT-754 Paradigm Veo MMT-1511 MiniMed 640G Insulin Pump MMT-1751 MiniMed 640G Insulin Pump MMT-1711 MiniMed 640G Pump MMT-1752 MiniMed 640G Insulin Pump MMT-554 Paradigm Veo MMT-1862 MiniMed 740G Kit MMT-1811 MiniMed 740G Pump MMT-1859 MiniMed 720G Kit MMT-1810 MiniMed 720G Pump MMT-1861 MiniMed 740G Kit MMT-1710 MiniMed 620G Pump MMT-1750 MiniMed 620G Kit MMT-1812 MiniMed 740G Pump MMT-1860 MiniMed 720G Kit MMT-886T MiniMed Sure-T MMT-864T MiniMed Sure-T MMT-876T MiniMed Sure-T MMT-874T MiniMed Sure-T MMT-862T MiniMed Sure-T MMT-866T MiniMed Sure-T MMT-870 MiniMed Sure-T MMT-884 MiniMed Sure-T MMT-884A MiniMed Sure-T MMT-860 MiniMed Sure-T MMT-875 MiniMed Sure-T MMT-863 MiniMed Sure-T MMT-873 MiniMed Sure-T MMT-885 MiniMed Sure-T MMT-883 MiniMed Sure-T MMT-865 MiniMed Sure-T

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only