Home GUDID 20194717119910 Regard™
Primary DI 20194717119910
Brand Regard™
Company ROI CPS, LLC
Model GS00176P
Device description ISOLATION BUNDLE KIT
Published 2024-08-14
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 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 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 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 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 10194717119913 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