FDA.reportPublic FDA data

Halyard

Primary DI
20809160493011
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
NAFB087-03_0002
Catalog number
NAFB087-03
Published
2025-08-29
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
20809160493011PackageGS12In Commercial Distribution
10809160493014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916049301120809160493011
1080916049301410809160493014

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method

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
10809160540497HALYARDBPKN15-02BPKN15-022026-10-12
10809160540510HALYARDBPCL47-02BPCL47-022026-10-12
10809160540527HALYARDBPEX22-02BPEX22-022026-10-12
10809160540534HALYARDBPLA73-02BPLA73-022026-10-12
10809160540541HALYARDBPSA20-02BPSA20-022026-10-12
10809160540558HALYARDGBPM39-02GBPM39-022026-10-12
10809160540428HalyardEURO017-10_0002EURO017-102026-10-09
10809160540435HalyardEAMC103-08_0005EAMC103-082026-10-09
10809160540442HalyardMAMC235-17_0001MAMC235-172026-10-09
10809160540459HalyardMAMC220-12_0002MAMC220-122026-10-09
10809160540466HalyardDNKN06_0012DNKN062026-10-09
10809160540091HalyardSGEP43-03_0005SGEP43-032026-10-08
10809160540114HalyardDNSP11_0008DNSP112026-10-08
10809160540121HalyardDNVP97_0006DNVP972026-10-08
10809160540138HalyardDNPP09_0011DNPP092026-10-08
10809160540145HalyardDNAG08_0011DNAG082026-10-08
10809160540152HalyardDNUR81_0005DNUR812026-10-08
10809160540169HalyardDULP98-03_0001DULP98-032026-10-08
10809160540176HalyardVAST024-08_0013VAST024-082026-10-08
10809160540183HalyardDUPR37-03_0001DUPR37-032026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956077348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956137547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956194632CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956471887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956518421CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956538467CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956541672CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956554085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956569362CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956575042CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956576957CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956581227CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956584372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586987CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956587212CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956591783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956596481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599178CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599185CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599383CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599451CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600324CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600560CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956601413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12