FDA.reportPublic FDA data

Regard™

Primary DI
20326053106839
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
CV0283
Published
2016-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
20326053106839PackageGS11Not in Commercial Distribution
10326053106832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605310683920326053106839
1032605310683210326053106832

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
945020902
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
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
00884450486436Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
00884450488812Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
10198956119437CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956345942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956360358CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956365056CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956418424CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956421479CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956439870CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956462182CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956480834CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956483408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956485662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956488861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956490871CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956491502CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492332CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956496415CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956502420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503915CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504011CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504325CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956507104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956511057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956512603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956514331CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956517639CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956518391CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09