Iradimed

Basic Information

• Brand Name: Iradimed
• Primary DI: 00856038001829
• Version / Model: 1190-12
• Catalog Number: 1190-12
• Company Name: IRADIMED CORP.
• Labeler DUNS: 170301969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 1
• Public Version Date: 2020-02-17
• Public Version Status: New
• Public Device Record Key: aedf6f45-0351-49ac-9356-1089c04366be

Device Description

Jacket, Disposable, POD

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62722	Electronic device storage cover, reusable	A non-sterile device intended to cover a portable electronic medical device while it is not in use to protect it from damage/contamination. The cover is often shaped for a specific type of portable electronic device and is intended to be removed before electronic device use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856038001829	GS1

Premarket Submissions

Submission Number	Supplement Number
K172200	000