FDA.reportPublic FDA data

Regard™

Primary DI
10194717102632
Brand
Regard™
Company
ROI CPS, LLC
Model
HT00026L
Published
2019-11-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEQAngiography/Angioplasty Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717102639PackageGS13Not in Commercial Distribution
10194717102632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710263920194717102639
1019471710263210194717102632

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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#

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
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956583931CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956586208CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956587342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588691CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588882CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588998CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589230CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589421CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956592605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956339255CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956504271CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956577664CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582149CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22