Home GUDID 00191072199454 ACS
Primary DI 00191072199454
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model AVPL66I
Device description PICC LINE INSERTION AKMC 154061
Published 2023-07-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00191072199454 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00191072199454 00191072199454 191072199454 0191072199454
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 010334675 Device count 1 Premarket exempt true Kit true Lot or batch true Serial number true Sterilization required before use 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 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