FDA Registration
Active
🇺🇸 United States
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Reg #: 3042027705
·
FEI: 3042027705
·
Expires 2026
Products
10
Proprietary Names
139
Establishment Types
4
Classifications
10
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Registration Details
- Registration Name
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Registration Number
- 3042027705
- FEI Number
- 3042027705
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK
- City
- Juncos
- State
- PR
- ZIP
- 00777
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001829
- PMA Number
- P160017
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2021-12-23 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2016-10-20 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-03-27 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2018-03-20 |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | Class 3 | Unknown | No | 2018-03-20 |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | Class 3 | Unknown | No | 2016-04-06 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2025-09-25 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2025-09-25 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2022-05-16 |
| Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System | SFI | Class 3 | Unknown | No | 2025-08-08 |
Proprietary Names
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-5120 Simplera Sync sensor
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-7715 Charger, Replacement (Grey)
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-7841 Guardian 4 Transmitter
MMT-7040 Guardian Sensor 4
MMT-1884L MiniMed 780G Insulin Pump
MMT-7840 Guardian 4 Transmitter Kit (GST5G)
MMT-1894 MiniMed 780G Insulin Pump Kit
MMT-503 MiniMed Paradigm Insulin Pump, Model 511
MMT-7736L Tester 2pk
MMT-7020MLA Guardian Sensor (3) 5pk
CSS7200 Guardian Connect App
MMT-7705 MiniLink Transmitter Charger, Replacement (Blue)
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-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-7008 Enlite Sensor
MMT-7706 MiniLink Tester Plug, Replacement
MMT-7510 Enlite Serter
MMT-7703 MiniLink REAL-Time Transmitter, Replacement (GST1)
MMT-332AT MiniMed Reservoir
MMT-326A MiniMed Reservoir
MMT-326AT MiniMed Reservoir
MMT-723 Paradigm Real-Time Revel Insulin Pump 3ml
MMT-7703 MiniLink REAL-Time Transmitter
MMT-7725 MiniLink Real-Time Transmitter Starter Kit (MMT-7703, 7705, 7706, 7510)
MMT-523 Paradigm Real-Time Revel Insulin Pump 1.8m
MMT-7735 MiniLink REAL-Time Transmitter
MMT-7726 Water Tight Tester (Plug), Replacement
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 Extended Supply Kit
MMT-1884 MiniMed 780G insulin pump
MiniMed Extended Supply Kit (MMT-445C)
MiniMed Extended Supply Kit (MMT-445B)
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-7745 iPro2
MMT-7008 ENLITE GLUCOSE SENSOR
MMT-7400 MiniMed Test Plug
MMT-7102 Continuous Glucose Monitor
MMT-7340 CareLink iPro
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
MMT-342 Extended Reservoir
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-103AT MiniMed Reservoir
MMT-103A MiniMed Reservoir
MEDTRONIC MINIMED INFUSION PUMP
MMT-751 MiniMed 530G Insulin Pump 3ml
MMT-7510 ENLITE Serter
MMT-551 MiniMed 530G Pump 1.8ml
MMT-7512 One-Press Serter
MMT-7774 MiniLink Real-Time Transmitter Starter Kit (GST1E)
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Repack or Relabel Medical Device
Remanufacture Medical Device