Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005053560

FEI Number

3005053560

Entity Name

IRADIMED CORPORATION

City/State/Country

Orlando, FL, US

Establishment Address

12705 Ingenuity Dr, Orlando, FL 32826, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IRADIMED CORPORATION (Owner Number: 9070201)

Owner / Operator Contact Address

12705 Ingenuity Dr., --, Orlando, FL 32826, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MRidium 3860 MRI Infusion Pump System 3880 MRI Patient Monitoring System MRidium IV Pole MRidium 3870 MRI Infusion Pump System 1000 Series IV Sets 1119 MRI IV Pole 3880 MRI Patient Monitoring System Mridium 3860+ MRI Infusion Pump/ Monitoring System 3880 MRI Patient Monitoring System Hextrode MRI ECG Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2009-12-28
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-11-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2005-04-11
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-05-05
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2026-05-05
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2026-05-05
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-10-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-10-25
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-10-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2017-11-13

Official Correspondent

Daniel Bennett

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRADIMED CORPORATION

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

View Entity Profile →

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
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005053560. Last updated year: 2026. Please use registration number 3005053560 when referencing this establishment in official correspondence.