Home GUDID 10194717120094 Regard™
Primary DI 10194717120094
Brand Regard™
Company ROI CPS, LLC
Model AN00007S
Device description PICC TRAY
Published 2024-10-02
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 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 20194717120091 Package GS1 10 Not in Commercial Distribution 10194717120094 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717120091 20194717120091 10194717120094 10194717120094
GMDN Terms# Term, Definition table Term Definition Central venous catheterization kit, short-term A collection of 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 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 10194717120162 Regard™ ROI CPS, LLC OKE 2024-10-08 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 10195594530761 CARDINAL HEALTH Cardinal Health 200, LLC OKE 2022-02-01 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