Home GUDID 20194717112553 Regard™
Primary DI 20194717112553
Brand Regard™
Company ROI CPS, LLC
Model AN01185
Device description ANESTHESIA CIRCUIT
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 false
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 20194717112553 Package GS1 14 In Commercial Distribution 10194717112556 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717112553 20194717112553 10194717112556 10194717112556
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 05707480162925 SPUR® II Infant Resuscitator Ambu A/S OEV 2025-06-06 20194717121029 Regard™ ROI CPS, LLC OEV 2025-02-18 30889483166295 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483166301 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483606029 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 30889483606043 SuperNO2VA Sunmed Group Holdings, LLC OEV 2025-02-14 20194717121036 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121043 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121050 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717121067 Regard™ ROI CPS, LLC OEV 2025-02-13 20194717120978 Regard™ ROI CPS, LLC OEV 2025-02-10 20194717120985 Regard™ ROI CPS, LLC OEV 2025-02-10 20194717120213 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120220 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120251 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120268 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120275 Regard™ ROI CPS, LLC OEV 2024-10-31 20194717120237 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120244 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120282 Regard™ ROI CPS, LLC OEV 2024-10-30 20194717120183 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120190 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120206 Regard™ ROI CPS, LLC OEV 2024-10-21 20194717120008 Regard™ ROI CPS, LLC OEV 2024-10-02 20194717120046 Regard™ ROI CPS, LLC OEV 2024-09-27 20194717119880 Regard™ ROI CPS, LLC OEV 2024-08-01 20194717119873 Regard™ ROI CPS, LLC OEV 2024-07-15 20194717119835 Regard™ ROI CPS, LLC OEV 2024-07-05 20194717119842 Regard™ ROI CPS, LLC OEV 2024-07-05 20194717119774 Regard™ ROI CPS, LLC OEV 2024-06-25