FDA.reportPublic FDA data

Regard™

Primary DI
10326053100557
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
CV0054
Published
2016-12-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
20326053100554PackageGS12Not in Commercial Distribution
10326053100557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605310055420326053100554
1032605310055710326053100557

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
945020902
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
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450163344Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-18
10809160527337HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527375HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527429HalyardAVID MEDICAL, INC.OEZ2026-07-17
00884450161777Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
00884450432075Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
10198956319929CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956326484CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956382381CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956395886CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956424524CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956446533CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956502376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956505148CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956508378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956512740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956513648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956514508CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956519992CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956525337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526242CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527782CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527898CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528130CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528277CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16