FDA.reportPublic FDA data

Halyard

Primary DI
10809160531907
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
DUEC27-01_0004
Catalog number
DUEC27-01
Published
2026-08-27
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
20809160531904PackageGS14In Commercial Distribution
10809160531907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053190420809160531904
1080916053190710809160531907

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
true
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
10809160531853HalyardDGAL24-03_0010DGAL24-032026-08-27
10809160531860HalyardDGBB41-02_0006DGBB41-022026-08-27
10809160531877HalyardDGIV63_0008DGIV632026-08-27
10809160531884HalyardDUAD22-01_0004DUAD22-012026-08-27
10809160531891HalyardDUCC54_0009DUCC542026-08-27
10809160531914HalyardSJGH109-07_0007SJGH109-072026-08-27
10809160531921HalyardSFSEURO028-07_0001SFSEURO028-072026-08-27
10809160531938HalyardSHND415-02_0001SHND415-022026-08-27
10809160531945HalyardSOTJ41-01_0007SOTJ41-012026-08-27
10809160531952HalyardNAMC425-08_0013NAMC425-082026-08-27
10809160531969HalyardWAFB224-03_0007WAFB224-032026-08-27
10809160531976HalyardSFSBAAK106-15_0001SFSBAAK106-152026-08-27
10809160531983HalyardSFSEABF007-15_0001SFSEABF007-152026-08-27
10809160531990HalyardSFSBUAH026-24_0001SFSBUAH026-242026-08-27
10809160532003HalyardSFSEAMC114-07_0001SFSEAMC114-072026-08-27
10809160532010HalyardWRNM004-18_0004WRNM004-182026-08-27
10809160532027HalyardEURO002-11_0005EURO002-112026-08-27
10809160532034HalyardSFSEURO010-10_0001SFSEURO010-102026-08-27
10809160532041HalyardEURO013-11_0005EURO013-112026-08-27
10809160532058HalyardSFSMAAH024-02_0001SFSMAAH024-022026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532072HalyardAVID MEDICAL, INC.OEZ2026-08-27
00884450437766Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-26
10198956346246CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956473836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956532243CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956534810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956545816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956547858CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956548138CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956549951CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956557314CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956559295CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956560963CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561755CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562158CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562165CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562318CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562868CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563353CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563407CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563711CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10809160531808HalyardAVID MEDICAL, INC.OEZ2026-08-26
00884450432082Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-25
10809160531600HalyardAVID MEDICAL, INC.OEZ2026-08-25