FDA.reportPublic FDA data

Halyard

Primary DI
10809160538647
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
WRNM015-12_0006
Catalog number
WRNM015-12
Published
2026-09-22
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
20809160538644PackageGS13In Commercial Distribution
10809160538647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053864420809160538644
1080916053864710809160538647

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
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538654HalyardWRNM024-17_0003WRNM024-172026-09-22
10809160538661HalyardLVMJ21-03_0014LVMJ21-032026-09-22
10809160538678HalyardWRNM026-18_0008WRNM026-182026-09-22
10809160538685HalyardLVRB53-01_0011LVRB53-012026-09-22
10809160538692HalyardLVHD29-03_0011LVHD29-032026-09-22
10809160538708HalyardEURO051-03_0003EURO051-032026-09-22
10809160538715HalyardWRNM085-03_0004WRNM085-032026-09-22
10809160538722HalyardBAAK100-12_0010BAAK100-122026-09-22
10809160538739HALYARDBPSA44-02BPSA44-022026-09-22
10809160538050HalyardVAMH009-06_0002VAMH009-062026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450435526Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
00884450445419Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
00884450473313Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
10198956508903CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956520554CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956520783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956524255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956547384CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956566750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956571464CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575950CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956578104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579347CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579606CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579682CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580572CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580657CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580817CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581289CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581531CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582101CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582460CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583351CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583429CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956584631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585171CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585812CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22