Home GUDID 10194717115144 Regard™
Primary DI 10194717115144
Brand Regard™
Company ROI CPS, LLC
Model HT00253H
Device description SPECIAL PROCEDURE
Published 2022-03-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OES Cardiac Catheterization Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OES Cardiac Catheterization Kit Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717115141 Package GS1 3 Not in Commercial Distribution 10194717115144 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717115141 20194717115141 10194717115144 10194717115144
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 117174678 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B098DDS1159D0 Aligned Medical Solutions Aligned Medical Solutions OES 2026-09-26 10198459754210 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459754524 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459755699 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459755705 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459758287 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459758294 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459759291 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459761850 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459766336 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459771224 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459774126 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459775437 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459775666 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459775673 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459775680 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459778827 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459779985 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459784996 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459786808 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459787690 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459788130 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459789717 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459789724 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459791994 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459792007 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459795138 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459796975 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459799143 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25 10198459809187 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-09-25