Home GUDID 20194717112560 Regard™
Primary DI 20194717112560
Brand Regard™
Company ROI CPS, LLC
Model AN01186
Device description ANESTHESIA CIRCUIT PEDIATRIC
Published 2021-07-22
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 OEV Cardiopulmonary Resuscitation Aid Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717112560 Package GS1 14 In Commercial Distribution 10194717112563 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717112560 20194717112560 10194717112563 10194717112563
GMDN Terms# Term, Definition table Term Definition Epidural anaesthesia set, non-medicated A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia 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 10194717121022 Regard™ ROI CPS, LLC OEV 2025-02-18 10889483166291 SuperNO2VA AIRLIFE OEV 2025-02-14 10889483166307 SuperNO2VA AIRLIFE OEV 2025-02-14 10889483606025 SuperNO2VA AIRLIFE OEV 2025-02-14 10889483606049 SuperNO2VA AIRLIFE OEV 2025-02-14 10194717121039 Regard™ ROI CPS, LLC OEV 2025-02-13 10194717121046 Regard™ ROI CPS, LLC OEV 2025-02-13 10194717121053 Regard™ ROI CPS, LLC OEV 2025-02-13 10194717121060 Regard™ ROI CPS, LLC OEV 2025-02-13 10194717120971 Regard™ ROI CPS, LLC OEV 2025-02-10 10194717120988 Regard™ ROI CPS, LLC OEV 2025-02-10 10194717120216 Regard™ ROI CPS, LLC OEV 2024-10-31 10194717120223 Regard™ ROI CPS, LLC OEV 2024-10-31 10194717120254 Regard™ ROI CPS, LLC OEV 2024-10-31 10194717120261 Regard™ ROI CPS, LLC OEV 2024-10-31 10194717120278 Regard™ ROI CPS, LLC OEV 2024-10-31 10194717120230 Regard™ ROI CPS, LLC OEV 2024-10-30 10194717120247 Regard™ ROI CPS, LLC OEV 2024-10-30 10194717120285 Regard™ ROI CPS, LLC OEV 2024-10-30 10194717120186 Regard™ ROI CPS, LLC OEV 2024-10-21 10194717120193 Regard™ ROI CPS, LLC OEV 2024-10-21 10194717120209 Regard™ ROI CPS, LLC OEV 2024-10-21 10194717120001 Regard™ ROI CPS, LLC OEV 2024-10-02 10194717120049 Regard™ ROI CPS, LLC OEV 2024-09-27 10194717119883 Regard™ ROI CPS, LLC OEV 2024-08-01 10194717119876 Regard™ ROI CPS, LLC OEV 2024-07-15 10194717119838 Regard™ ROI CPS, LLC OEV 2024-07-05 10194717119845 Regard™ ROI CPS, LLC OEV 2024-07-05 10194717119777 Regard™ ROI CPS, LLC OEV 2024-06-25 10194717119784 Regard™ ROI CPS, LLC OEV 2024-06-25