FDA.reportPublic FDA data

Regard™

Primary DI
20194717103704
Brand
Regard™
Company
ROI CPS, LLC
Model
CV00188P
Published
2019-11-21
Public version status
Update
Distribution status
Not 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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717103704PackageGS12Not in Commercial Distribution
10194717103707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710370420194717103704
1019471710370710194717103707

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.

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
true
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
00884450107072Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450161746Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450436745Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
10198956321557CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956330085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956339231CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956353268CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956402973CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956415058CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956433007CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956451278CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956474963CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956477872CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956479470CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956482098CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956483798CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956485235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956488243CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956488427CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956489646CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956490123CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491021CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491779CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491977CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956492561CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493407CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493759CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05