Home GUDID 10194717104193 Regard™
Primary DI 10194717104193
Brand Regard™
Company ROI CPS, LLC
Model HT00331H
Published 2019-10-31
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 20194717104190 Package GS1 4 Not in Commercial Distribution 10194717104193 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717104190 20194717104190 10194717104193 10194717104193
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 10198956478107 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-09 10198956518131 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-09 10198956526983 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-09 10198956528208 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-09 10809160526859 Halyard AVID MEDICAL, INC. OES 2026-07-08 10198956463400 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-06 10198956525993 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-07-06 10809160526361 Halyard AVID MEDICAL, INC. OES 2026-06-26 10809160526262 Halyard AVID MEDICAL, INC. OES 2026-06-25 10809160525937 Halyard AVID MEDICAL, INC. OES 2026-06-24 10809160525968 Halyard AVID MEDICAL, INC. OES 2026-06-24 10809160526019 Halyard AVID MEDICAL, INC. OES 2026-06-24 10809160526132 Halyard AVID MEDICAL, INC. OES 2026-06-24 10198956415553 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-23 10809160525869 Halyard AVID MEDICAL, INC. OES 2026-06-23 10809160525890 HALYARD AVID MEDICAL, INC. OES 2026-06-23 10809160525234 Halyard AVID MEDICAL, INC. OES 2026-06-22 10809160525555 Halyard AVID MEDICAL, INC. OES 2026-06-22 10809160525579 Halyard AVID MEDICAL, INC. OES 2026-06-22 10809160523148 Halyard AVID MEDICAL, INC. OES 2026-06-09 10809160523193 Halyard AVID MEDICAL, INC. OES 2026-06-09 10198956483590 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-08 10198956490512 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-08 10198956496224 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-08 10198956506718 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-08 10809160522981 Halyard AVID MEDICAL, INC. OES 2026-06-08 10198956471757 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-05 10198956495777 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-05 10809160522639 Halyard AVID MEDICAL, INC. OES 2026-06-04 10198956459960 CARDINAL HEALTH Cardinal Health 200, LLC OES 2026-06-03