FDA.reportPublic FDA data

Regard™

Primary DI
20326053113059
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
UR0858
Published
2017-04-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
20326053113059PackageGS110Not in Commercial Distribution
10326053113052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605311305920326053113059
1032605311305210326053113052

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
945020902
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
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

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
20194717102301Regard™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
10326053112970Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16
20326053112977Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16