FDA.reportPublic FDA data

Halyard

Primary DI
10809160537671
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAIC017-07_0004
Catalog number
VAIC017-07
Published
2026-09-19
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
20809160537678PackageGS12In Commercial Distribution
10809160537671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053767820809160537678
1080916053767110809160537671

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
10809160542224HalyardMARS002-06_0002MARS002-062026-10-29
10809160542231HalyardSOLC12A-01_0005SOLC12A-012026-10-29
10809160542248HalyardASAB78-04_0002ASAB78-042026-10-29
10809160542163HALYARDHHIR34-03HHIR34-032026-10-28
10809160542200HalyardEURO017-11_0003EURO017-112026-10-28
10809160541944HALYARDMSMC123-04MSMC123-042026-10-27
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
10809160541616HalyardVAPX013-06_0013VAPX013-062026-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956595224CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
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10198956607040CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
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10198956612235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
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10198956619463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956619845CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620360CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620841CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956622272CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29