FDA.reportPublic FDA data

Regard™

Primary DI
20194717120121
Brand
Regard™
Company
ROI CPS, LLC
Model
HT00001S
Device description
ANGIO
Published
2024-10-02
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
OEQAngiography/Angioplasty Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717120121PackageGS16In Commercial Distribution
10194717120124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712012120194717120121
1019471712012410194717120124

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.

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
false
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
00884450487341Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-10
10198956307308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956349834CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956368163CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956470897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956483651CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956485143CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956491588CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956499959CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956504035CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956517752CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956521650CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956524750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525832CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956526174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527249CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527645CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527744CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528086CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528222CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528246CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
00884450487273Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-08
10198956373655CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956416482CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956514119CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956515789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956516083CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956517844CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956518025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06