FDA.reportPublic FDA data

Regard™

Primary DI
20194717102301
Brand
Regard™
Company
ROI CPS, LLC
Model
UR00858B
Published
2019-10-28
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
CodeName
PPABladder Irrigation Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPABladder Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717102301PackageGS110In Commercial Distribution
10194717102304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710230120194717102301
1019471710230410194717102304

GMDN Terms#

Term, Definition table
TermDefinition
Bladder irrigation kitA collection of sterile devices designed for the infusion of fluids used to flush and evacuate the bladder of urine and other particulate matter. It typically includes tubing, connectors, a syringe, a roller clamp and other items used to flush the bladder. It may also be indicated for use in such procedures as a cystoscopy or a transurethral resection (TUR) as a means of continuous bladder irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194717102298Regard™UR00857C2019-11-21
10194717102304Regard™UR00858B2019-10-28
10194717111733Regard™GS00372E2025-03-30
10194717112488Regard™GS00237H2021-07-19
10194717112990Regard™LD01002CD2021-08-24
10194717113959Regard™GS00310D2021-11-29
10194717113973Regard™GS00311C2021-11-29
10194717114741Regard™PL00126ST2022-02-17
10194717115144Regard™HT00253H2022-03-23
10194717115175Regard™CV00256LM2022-03-23
10194717115830Regard™PL00126T2022-04-28
10194717116028Regard™ET00701GH2022-06-28
10194717116066Regard™HT00253I2022-07-14
10194717121305Regard™GS01065D2025-01-21
20194717102295Regard™UR00857C2019-11-21
10194717100355Regard™UR00279I2019-10-28
10194717100812Regard™UR00847B2019-11-14
10194717104797Regard™UR00739I2019-11-07
10194717104834Regard™UR00746G2019-10-28
10194717106609Regard™UR00746H2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160429372Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
20809160429379Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
10809160372982MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
20809160372989MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
10195594345419CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
50195594345417CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
10195594277345CARDINAL HEALTHCardinal Health 200, LLCPPA2021-08-20
50195594277343CARDINAL HEALTHCardinal Health 200, LLCPPA2021-08-20
00616784426624Irrigation Tray with 60cc Bulb SyringesDynarex CorporationPPA2021-06-21
00616784426822Irrigation Tray with 60cc Piston SyringeDynarex CorporationPPA2021-06-21
10195594963880CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
50195594963888CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
10194717102281Regard™ROI CPS, LLCPPA2020-01-03
20194717102288Regard™ROI CPS, LLCPPA2020-01-03
10194717102298Regard™ROI CPS, LLCPPA2019-11-21
20194717102295Regard™ROI CPS, LLCPPA2019-11-21
10194717102304Regard™ROI CPS, LLCPPA2019-10-28
10809160201503MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
20809160201500MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
10326053113045Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053113052Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113042Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113059Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053112970Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16
20326053112977Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16