FDA.reportPublic FDA data

Halyard

Primary DI
10809160528020
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
KOOT802-03_0004
Catalog number
KOOT802-03
Published
2026-07-28
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

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
20809160528027PackageGS112In Commercial Distribution
10809160528020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052802720809160528027
1080916052802010809160528020

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. 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 intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528129HalyardNAMC434-09_0002NAMC434-092026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528181HalyardQCEORSP123_0001QCEORSP1232026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527870HALYARDPVHM201-02PVHM201-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450498996Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-30
10809160528150HalyardAVID MEDICAL, INC.OEZ2026-07-30
10809160528167HalyardAVID MEDICAL, INC.OEZ2026-07-30
00884450431672Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-29
00884450144046Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-28
10198956423527CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956442191CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956459830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956477131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956478893CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956482449CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956493605CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956494770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956496187CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956499379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956504684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505674CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956514188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516878CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956518742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956520684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521513CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524163CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27