FDA.reportPublic FDA data

Halyard

Primary DI
10809160522981
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AVMD016-02_0005
Catalog number
AVMD016-02
Published
2026-06-08
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160522988PackageGS120In Commercial Distribution
10809160522981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052298820809160522988
1080916052298110809160522981

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08
10809160522844HalyardSFSJACK435-09_0001SFSJACK435-092026-06-08
10809160522851HalyardBMHU003-05_0001BMHU003-052026-06-08
10809160522868HalyardSFSMSBM022-06_0001SFSMSBM022-062026-06-08
10809160522875HalyardMSBM030-06_0007MSBM030-062026-06-08
10809160522882HalyardMSBM022-06_0006MSBM022-062026-06-08
10809160522899HalyardJACK435-09_0005JACK435-092026-06-08
10809160522905HalyardSFSMSBM030-06_0002SFSMSBM030-062026-06-08
10809160522912HalyardJACK455-05_0001JACK455-052026-06-08
10809160522929HalyardSFSJCLC12-01_0001SFSJCLC12-012026-06-08
10809160522936HalyardSHAN453-04_0015SHAN453-042026-06-08
10809160522943HalyardBMHT030-05_0003BMHT030-052026-06-08
10809160522950HalyardMAMC229-22_0001MAMC229-222026-06-08
10809160522967HalyardACTK56-03_0008ACTK56-032026-06-08
10809160522974HalyardDGAL24-03_0007DGAL24-032026-06-08
10809160522998HalyardMEHY02O_0011MEHY02O2026-06-08
10809160523001HalyardMCBP83-02_0005MCBP83-022026-06-08
10809160523018HalyardMAMC213-09_0004MAMC213-092026-06-08
10809160523025HalyardSGCY35-01_0005SGCY35-012026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956483590CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-08
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10198956471757CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10198956495777CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10809160522639HalyardAVID MEDICAL, INC.OES2026-06-04
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10198956490734CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956492325CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956494206CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
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