Home GUDID 20194717102295 Regard™
Primary DI 20194717102295
Brand Regard™
Company ROI CPS, LLC
Model UR00857C
Published 2019-11-21
Public version status Update
Distribution status Not 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 PPA Bladder Irrigation Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPA Bladder Irrigation Kit Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717102295 Package GS1 16 Not in Commercial Distribution 10194717102298 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717102295 20194717102295 10194717102298 10194717102298
GMDN Terms# Term, Definition table Term Definition Urological surgical procedure kit, non-medicated, single-use A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. 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 true 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 10809160429372 Medical Action Industries MEDICAL ACTION INDUSTRIES INC. PPA 2024-07-09 20809160429379 Medical Action Industries MEDICAL ACTION INDUSTRIES INC. PPA 2024-07-09 10809160372982 MEDICAL ACTION INDUSTRIES MEDICAL ACTION INDUSTRIES INC. PPA 2022-06-10 20809160372989 MEDICAL ACTION INDUSTRIES MEDICAL ACTION INDUSTRIES INC. PPA 2022-06-10 10195594345419 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-10-12 50195594345417 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-10-12 10195594277345 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-08-20 50195594277343 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-08-20 00616784426624 Irrigation Tray with 60cc Bulb Syringes Dynarex Corporation PPA 2021-06-21 00616784426822 Irrigation Tray with 60cc Piston Syringe Dynarex Corporation PPA 2021-06-21 10195594963880 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-05-03 50195594963888 CARDINAL HEALTH Cardinal Health 200, LLC PPA 2021-05-03 10194717102281 Regard™ ROI CPS, LLC PPA 2020-01-03 20194717102288 Regard™ ROI CPS, LLC PPA 2020-01-03 10194717102298 Regard™ ROI CPS, LLC PPA 2019-11-21 10194717102304 Regard™ ROI CPS, LLC PPA 2019-10-28 20194717102301 Regard™ ROI CPS, LLC PPA 2019-10-28 10809160201503 MEDICAL ACTION INDUSTRIES MEDICAL ACTION INDUSTRIES INC. PPA 2018-07-27 20809160201500 MEDICAL ACTION INDUSTRIES MEDICAL ACTION INDUSTRIES INC. PPA 2018-07-27 10326053113045 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-04-20 10326053113052 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-04-20 20326053113042 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-04-20 20326053113059 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-04-20 10326053112970 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-02-16 20326053112977 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. PPA 2017-02-16