FDA.reportPublic FDA data

Regard™

Primary DI
10194717106579
Brand
Regard™
Company
ROI CPS, LLC
Model
CV00932C
Published
2020-01-13
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
20194717106576PackageGS11Not in Commercial Distribution
10194717106579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710657620194717106576
1019471710657910194717106579

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
Contains natural rubber latex
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
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450486962Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
10809160523162HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523179HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523186HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523209HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523216HalyardAVID MEDICAL, INC.OEZ2026-06-09
10198956182264CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956394766CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956444454CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956473263CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956477643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956478824CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956483880CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956493520CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956494282CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956495166CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956495272CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496194CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496491CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496538CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496729CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496736CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496743CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956496828CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497627CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497795CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956497863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08