FDA.reportPublic FDA data

Regard™

Primary DI
20194717101984
Brand
Regard™
Company
ROI CPS, LLC
Model
HT01074
Published
2020-01-16
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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717101984PackageGS110In Commercial Distribution
10194717101987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710198420194717101984
1019471710198710194717101987

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
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521816HalyardAVID MEDICAL, INC.OEZ2026-05-26
10809160521823HalyardAVID MEDICAL, INC.OEZ2026-05-26
10198956359949CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956377790CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956378254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956382701CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956421394CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956422308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956439337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956442405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956443716CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956453203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956459359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956460485CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956466333CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956466968CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956470170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956473164CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956480582CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480827CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956481770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484542CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956484610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956485211CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486478CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486669CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486768CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486829CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25