Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042027705

FEI Number

3042027705

Entity Name

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

City/State/Country

Juncos, PR, US

Establishment Address

ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK, Juncos, PR 00777, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic (Owner Number: 10094334)

Owner / Operator Contact Address

18000 Devonshire Street, Northridge, CA 91325, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P980022

All Registered 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 MMT-7512 One-press Serter CSS7200 Guardian Connect App MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) MMT-7020 Enlite 3 Sensor 5pk 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-7715 Charger, Replacement (Grey) 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-7512 One-press Serter MMT-7726 Watertight Tester MMT-7715 Charger, Replacement (Grey) MMT-7008 Enlite Sensor MMT-7810 Guardian Link 3 Transmitter Kit (GST3C) MMT-7811 Guardian Link 3 Transmitter (GST3C) MMT-7020 Enlite 3 Sensor 5pk MMT-7736 Tester 2pk MMT-7706 MiniLink Tester Plug, Replacement MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) MMT-7510 Enlite Serter MMT-7703 MiniLink REAL-Time Transmitter, Replacement (GST1) MMT-332A MiniMed Reservoir 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-7008 Enlite Sensor MMT-7706 MiniLink Tester Plug, Replacement MMT-7726 Water Tight Tester (Plug), Replacement MMT-7510 Enlite Serter 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-523 Paradigm Real-Time Revel Insulin Pump 1.8m MMT-7745 iPro2 MMT-7008 ENLITE GLUCOSE SENSOR MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) 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-7703 MiniLink REAL-Time Transmitter, Replacement (GST1) 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-7735 MiniLink REAL-Time Transmitter MMT-7706 MiniLink Tester Plug, Replacement 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-7726 Water Tight Tester (Plug), Replacement MMT-523 Paradigm REAL-Time Revel Insulin Pump MMT-723 Paradigm Real-Time Revel Insulin Pump 3ml 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2021-12-23
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2016-10-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-03-27
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2018-03-20
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2018-03-20
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2018-03-20
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2016-08-15
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-01-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-01-29
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2016-04-06
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown	Class 3	N/A	2016-04-06
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2021-06-08
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-09-25
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2025-09-25
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown	Class 3	N/A	2007-12-06
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2007-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2025	Medtronic MiniMed, Inc.	3	MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Z-0003-2025	Medtronic MiniMed, Inc.	3	MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Similar Registrations

Registration Number	Establishment Name	Location
3038419886	Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, PL
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US
3013756811	Tandem Diabetes Care, INC.	San Diego, CA, US
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US
3007939342	IntriCon Corporation VH	Vadnais Heights, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042027705. Last updated year: 2026. Please use registration number 3042027705 when referencing this establishment in official correspondence.