Iradimed

Basic Information

• Brand Name: Iradimed
• Primary DI: 00856038001096
• Version / Model: 3865
• Catalog Number: 3865
• Company Name: IRADIMED CORP.
• Labeler DUNS: 170301969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 94c2cf6a-314b-49d1-aaff-5c16e14159bb

Device Description

MRIDIUM 3865 REMOTE MONITOR

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LDR	Controller, Infusion, Intravascular, Electronic	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61584	Infusion pump remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an infusion pump (e.g., analgesia infusion pump, insulin infusion pump) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856038001096	GS1

Premarket Submissions

Submission Number	Supplement Number
K090087	000