FDA.reportPublic FDA data

Halyard

Primary DI
10809160541616
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAPX013-06_0013
Catalog number
VAPX013-06
Published
2026-10-26
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
10809160541616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916054161610809160541616

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
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
10809160541548HalyardVAPX008-09_0018VAPX008-092026-10-26
10809160541555HalyardVAPX007-09_0021VAPX007-092026-10-26
10809160541562HalyardVAPX012-07_0009VAPX012-072026-10-26
10809160541579HalyardVAPX014-08_0012VAPX014-082026-10-26
10809160541586HalyardVAPX015-12_0016VAPX015-122026-10-26
10809160541593HalyardSAMM021-12_0008SAMM021-122026-10-26
10809160541609HalyardUSAR042-23_0002USAR042-232026-10-26
10809160541623HalyardVAPX018-12_0014VAPX018-122026-10-26
10809160541630HalyardVAPX019-07_0029VAPX019-072026-10-26
10809160541647HalyardVAPX020-09_0020VAPX020-092026-10-26
10809160541654HalyardVAPX022-06_0021VAPX022-062026-10-26
10809160541661HalyardVAPX019-07_0001VAPX019-072026-10-26
10809160541678HalyardVAPX036-07_0027VAPX036-072026-10-26
10809160541685HalyardVAPX035-06_0016VAPX035-062026-10-26
10809160541692HalyardVAPX125-06_0017VAPX125-062026-10-26
10809160541708HalyardDNUR81_0007DNUR812026-10-26
10809160541715HalyardVAPX126-02_0019VAPX126-022026-10-26
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23
10809160541364HalyardMMBF007-04_0004MMBF007-042026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956611023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956612846CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956613379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956614062CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956616875CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956621510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10809160541562HalyardAVID MEDICAL, INC.OEZ2026-10-26
10809160541579HalyardAVID MEDICAL, INC.OEZ2026-10-26
00884450431542Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-24
10198956409552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956571259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956579378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956592049CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956601147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956602687CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956604179CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956605459CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606029CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606609CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956607620CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608474CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608818CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609198CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609860CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610026CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610125CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956611160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956612440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23