Regard

Basic Information

• Brand Name: Regard
• Primary DI: 10194717108894
• Version / Model: HT00468H
• Company Name: ROI CPS, LLC
• Labeler DUNS: 117174678
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-10
• Public Version: 2
• Public Version Date: 2020-12-23
• Public Version Status: Update
• Public Device Record Key: b34a809f-1786-4460-bcc2-144941b3b7e0
• Distribution End Date: 2020-12-23

Device Description

Pacemaker

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OES	Cardiac Catheterization Kit	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46362	Fluid/device delivery cardiac catheter	A sterile, steerable, flexible tube containing electrodes intended to be introduced percutaneously into the heart chambers in order to provide a pathway for the controlled delivery and support of a selective infusion of fluids or transvenous devices to the heart (e.g., the coronary sinus) and coronary vasculature. It may also be used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite and have an actuator mechanism located at the proximal end used to steer the tip in the desired direction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194717108891	GS1		3	Not in Commercial Distribution	2020-12-23
Primary	10194717108894	GS1