FDA.reportPublic FDA data

Regard™

Primary DI
20194717118302
Brand
Regard™
Company
ROI CPS, LLC
Model
HT00906D
Device description
ANGIO SPECIAL PROCEDURE
Published
2024-01-19
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
20194717118302PackageGS13In Commercial Distribution
10194717118305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711830220194717118302
1019471711830510194717118305

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
10193489078114NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078213NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078220NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489213430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489410013Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489413458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489423372Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489424003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489425147Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489433111Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489448917Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489449198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489453645Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489455885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489456172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489458121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489037517MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037524MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037531MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037548MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037555MedlineMEDLINE INDUSTRIES, INC.OEQ2023-05-30
H65857032425Henry ScheinHENRY SCHEIN, INC.OEQ2023-01-10
10193489444551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-09-04
10193489078121NAMICMEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489248760Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489665727Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489457223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-07-24
10193489461534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-06-11
H65857029605Henry ScheinHENRY SCHEIN, INC.OEQ2022-04-05
H65857029435Henry ScheinHENRY SCHEIN, INC.OEQ2022-03-31