FDA.reportPublic FDA data

Halyard

Primary DI
10809160530634
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SHAN413-06_0001
Catalog number
SHAN413-06
Published
2026-08-18
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
10809160530634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053063410809160530634

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
10809160530696HalyardPVHM227-02_0003PVHM227-022026-08-19
10809160530702HalyardPVHM224-02_0005PVHM224-022026-08-19
10809160530719HalyardPVHM218-02_0002PVHM218-022026-08-19
10809160530726HalyardPVHM220-02_0002PVHM220-022026-08-19
10809160530733HalyardPVHM207-02_0001PVHM207-022026-08-19
10809160530740HalyardPVHM201-02_0004PVHM201-022026-08-19
10809160530757HalyardPVHM205-02_0003PVHM205-022026-08-19
10809160530764HalyardPVHM221-02_0001PVHM221-022026-08-19
10809160530771HalyardPVHM216-02_0003PVHM216-022026-08-19
10809160530788HalyardPVHM223-02_0005PVHM223-022026-08-19
10809160530795HalyardPVHM214-02_0002PVHM214-022026-08-19
10809160530801HalyardPVHM211-01_0002PVHM211-012026-08-19
10809160530818HalyardPVHM219-02_0002PVHM219-022026-08-19
10809160530825HalyardPVHM225-01_0004PVHM225-012026-08-19
10809160530832HalyardPVHM208-02_0005PVHM208-022026-08-19
10809160530894HalyardNCDS018-02_0010NCDS018-022026-08-19
10809160530900HalyardPVHM229-02_0006PVHM229-022026-08-19
10809160530252HalyardSHAN426-09_0003SHAN426-092026-08-18
10809160530269HalyardSJGH104-07_0002SJGH104-072026-08-18
10809160530276HalyardSHAN408-05_0003SHAN408-052026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450148228Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-19
10809160530795HalyardAVID MEDICAL, INC.OEZ2026-08-19
10198956502512CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956539082CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956548084CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956556881CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557789CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10809160530252HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530337HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530535HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530665HalyardAVID MEDICAL, INC.OEZ2026-08-18
10198956494800CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956500501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956522619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956535053CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956548770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956549418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550919CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956553293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
B098AMS196180Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-08-16
00884450467220Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-14