Home GUDID 20194717105753 Regard™
Primary DI 20194717105753
Brand Regard™
Company ROI CPS, LLC
Model AN01041E
Published 2019-12-10
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 OKE Port Introducer Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OKE Port Introducer Kit General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717105753 Package GS1 4 In Commercial Distribution 10194717105756 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717105753 20194717105753 10194717105756 10194717105756
GMDN Terms# Term, Definition table Term Definition Central venous catheterization kit, short-term A collection of sterile devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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 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 10194717120162 Regard™ ROI CPS, LLC OKE 2024-10-08 10194717120094 Regard™ ROI CPS, LLC OKE 2024-10-02 10194717119807 Regard™ ROI CPS, LLC OKE 2024-06-26 10194717119234 Regard™ ROI CPS, LLC OKE 2024-04-12 10194717118336 Regard™ ROI CPS, LLC OKE 2024-01-26 10194717117551 Regard™ ROI CPS, LLC OKE 2023-06-21 10194717116660 Regard™ ROI CPS, LLC OKE 2023-01-13 10195594396510 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-04-29 10195594519599 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-04-21 10194717115717 Regard™ ROI CPS, LLC OKE 2022-04-14 10195594443092 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-02-26 10195594463663 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-02-18 10195594510978 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-02-07 10195594385910 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-28 10195594423025 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-28 10195594456214 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-28 10195594508517 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-25 10195594530501 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-25 10195594518288 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-23 10194717114437 Regard™ ROI CPS, LLC OKE 2022-01-13 10195594429225 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-13 10195594485108 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-13 10195594499464 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-07 10195594486945 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-01-04 10195594285456 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-30 10195594496050 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-30 10195594504755 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-28 10195594434274 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-22 10195594493004 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-22 10195594413910 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2021-12-16