FDA.reportPublic FDA data

Regard™

Primary DI
10194717120797
Brand
Regard™
Company
ROI CPS, LLC
Model
HT00026N
Device description
ANGIOGRAPHY DRAPE KIT
Published
2024-12-04
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
20194717120794PackageGS13Not in Commercial Distribution
10194717120797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712079420194717120794
1019471712079710194717120797

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
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956420526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956504578CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956517332CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956542228CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956551251CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956556157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956581715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956589049CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956590557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956592711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956593947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956594685CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596726CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06