Home GUDID 20194717114410 Regard™
Primary DI 20194717114410
Brand Regard™
Company ROI CPS, LLC
Model CV00979B
Device description CV MINOR KIT
Published 2022-01-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OEZ Cardiovascular Procedure Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEZ Cardiovascular Procedure Kit Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717114410 Package GS1 15 In Commercial Distribution 10194717114413 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717114410 20194717114410 10194717114413 10194717114413
GMDN Terms# Term, Definition table Term Definition Cardiothoracic surgical procedure kit, non-medicated, single-use A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.
Regulatory Flags# DUNS number 117174678 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 true 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 00884450428313 Merit Medical® Merit Medical Systems, Inc. OEZ 2026-05-28 00884450487532 Merit Medical® Merit Medical Systems, Inc. OEZ 2026-05-28 10809160522042 Halyard AVID MEDICAL, INC. OEZ 2026-05-28 10809160522066 Halyard AVID MEDICAL, INC. OEZ 2026-05-28 10809160522097 Halyard AVID MEDICAL, INC. OEZ 2026-05-28 10809160521984 Halyard AVID MEDICAL, INC. OEZ 2026-05-27 H65857031555 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031565 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031315 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-10 H65857030865 Henry Schein HENRY SCHEIN, INC. OEZ 2022-05-25 H65857029425 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 H65857029535 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 10193489040166 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040180 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040197 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040203 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040210 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040227 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040234 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040241 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040258 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040265 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040272 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040289 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040296 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040302 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040319 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040326 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040333 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040340 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28