FDA.report

Regard™

Primary DI
20194717112669
Brand
Regard™
Company
ROI CPS, LLC
Model
CV00283M
Device description
OPEN HRT A&B
Published
2021-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717112669PackageGS11In Commercial Distribution
10194717112662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471711266920194717112669
1019471711266210194717112662

GMDN Terms

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

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 DIBrandModelCatalogPublished
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10809160521816HalyardAVID MEDICAL, INC.OEZ2026-05-26
10809160521823HalyardAVID MEDICAL, INC.OEZ2026-05-26
10198956359949CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956377790CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956382701CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956439337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956442405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956443716CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956453203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956459359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956466333CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956470170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480582CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480827CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956481770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956485211CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486829CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486867CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956487864CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488199CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488335CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488694CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488731CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956489554CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956490413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
00884450437049Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-23