FDA.reportPublic FDA data

Halyard

Primary DI
10809160532072
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFSNAMC446-11_0001
Catalog number
SFSNAMC446-11
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
10809160532072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053207210809160532072

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, forceps, scissors, scalpel, 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.

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
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
10809160531907HalyardDUEC27-01_0004DUEC27-012026-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531907HalyardAVID 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