Iradimed

Basic Information

• Brand Name: Iradimed
• Primary DI: 00856038001355
• Version / Model: 3880-4
• Catalog Number: 3880-4
• Company Name: IRADIMED CORP.
• Labeler DUNS: 170301969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-09
• Public Version: 1
• Public Version Date: 2022-06-17
• Public Version Status: New
• Public Device Record Key: b2ff5bb1-e1fb-4a70-92f3-f24d6a123c81

Device Description

3880 MRI Basic Monitor System + Temp & ETCO2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61161	MRI-patient physiologic monitoring system	A mobile assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of infant to adult intensive care patients during a magnetic resonance imaging (MRI) procedure. It includes an MRI patient monitor, sensors/electrodes (e.g., ECG electrodes, pulse oximetry telemetric transmitter, blood pressure cuff), and typically an additional remote monitor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856038001355	GS1

Premarket Submissions

Submission Number	Supplement Number
K172200	000