Home GUDID 20326053106754 Regard™
Primary DI 20326053106754
Brand Regard™
Company RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model HT0253
Published 2016-11-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
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 20326053106754 Package GS1 3 Not in Commercial Distribution 10326053106757 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20326053106754 20326053106754 10326053106757 10326053106757
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 945020902 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10809160521847 Halyard AVID MEDICAL, INC. OES 2026-05-26 10198956478855 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-05-25 10198956485457 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-05-25 10198956486775 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-05-25 10198956488618 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-05-25 20809160517236 Halyard AVID MEDICAL, INC. OES 2026-03-24 50198956364194 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-23 50198956380385 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-23 50198956415070 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-23 50198956433234 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-23 20809160517120 Halyard AVID MEDICAL, INC. OES 2026-03-23 20809160516871 Halyard AVID MEDICAL, INC. OES 2026-03-20 20809160516895 Halyard AVID MEDICAL, INC. OES 2026-03-20 20809160516956 Halyard AVID MEDICAL, INC. OES 2026-03-20 50198956404272 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-19 50198956410518 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-19 50198956412826 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-03-19 40198459589899 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459594985 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459611538 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459611552 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459611569 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459611576 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459613556 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459616618 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459616625 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459616632 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459616649 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459619466 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16 40198459619770 MEDLINE MEDLINE INDUSTRIES, INC. OES 2026-03-16