FDA.reportPublic FDA data

Regard™

Primary DI
10194717115175
Brand
Regard™
Company
ROI CPS, LLC
Model
CV00256LM
Device description
PERIPHERAL VASC
Published
2022-03-23
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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717115172PackageGS12Not in Commercial Distribution
10194717115175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711517220194717115172
1019471711517510194717115175

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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
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
10194717110422Regard™UR011502021-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537848HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537978HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537626HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537671HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537770HalyardAVID MEDICAL, INC.OEZ2026-09-19
00884450265260Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450277164Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450306635Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450336922Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450428955Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450431740Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450432068Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450442050Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450486931Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450488867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
10809160536315HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160536407HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537091HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537107HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537312HalyardAVID MEDICAL, INC.OEZ2026-09-18
B098AMS195520Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-18
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04