Iradimed

Basic Information

• Brand Name: Iradimed
• Primary DI: 00856038001133
• Version / Model: 1128
• Catalog Number: 1128
• 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: 26cce743-ba0a-41f9-a681-21a400813b14

Device Description

AC POWER CORD, HOSPITAL GRADE, 10.0 FT.

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: 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
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856038001133	GS1

Premarket Submissions

Submission Number	Supplement Number
K090087	000