Home GUDID 10194717119913 Regard™
Primary DI 10194717119913
Brand Regard™
Company ROI CPS, LLC
Model GS00176P
Device description ISOLATION BUNDLE KIT
Published 2024-08-14
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PXC Personal Protection Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PXC Personal Protection Kit General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717119910 Package GS1 4 Not in Commercial Distribution 10194717119913 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717119910 20194717119910 10194717119913 10194717119913
GMDN Terms# Term, Definition table Term Definition Surgical/examination garment kit A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). 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 00842209136025 NAR NORTH AMERICAN RESCUE, LLC PXC 2025-08-25 10194717120070 Regard™ ROI CPS, LLC PXC 2024-10-02 10194717120131 Regard™ ROI CPS, LLC PXC 2024-10-02 20194717120077 Regard™ ROI CPS, LLC PXC 2024-10-02 20194717120138 Regard™ ROI CPS, LLC PXC 2024-10-02 20194717119910 Regard™ ROI CPS, LLC PXC 2024-08-14 10194717119746 Regard™ ROI CPS, LLC PXC 2024-06-20 20194717119743 Regard™ ROI CPS, LLC PXC 2024-06-20 00842209130665 NAR NORTH AMERICAN RESCUE, LLC PXC 2024-04-29 10194717116042 Regard™ ROI CPS, LLC PXC 2022-07-11 20194717116049 Regard™ ROI CPS, LLC PXC 2022-07-11 M7526892650 STRADIS HEALTHCARE STRADIS MEDICAL, LLC PXC 2022-03-21 M7526871050 STRADIS HEALTHCARE STRADIS MEDICAL, LLC PXC 2022-03-17 M7526894290 STRADIS HEALTHCARE STRADIS MEDICAL, LLC PXC 2022-03-14 M7526891530 STRADIS HEALTHCARE STRADIS MEDICAL, LLC PXC 2022-03-02 00612479259102 McKesson MCKESSON MEDICAL-SURGICAL INC. PXC 2022-02-03 00612479259126 McKesson MCKESSON MEDICAL-SURGICAL INC. PXC 2022-02-03 00612479259119 McKesson MCKESSON MEDICAL-SURGICAL INC. PXC 2022-02-03 00612479259133 McKesson MCKESSON MEDICAL-SURGICAL INC. PXC 2022-02-03 00816703025727 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00840155403338 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00840155403369 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00816703025734 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00840155403345 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00840155403376 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-08-03 00816703028544 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-07-22 00816703028568 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-07-22 00816703028582 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-07-22 00816703028605 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-07-22 00816703028551 MedSource Gloves MEDSOURCE INTERNATIONAL LLC PXC 2021-07-22