FDA.reportPublic FDA data

Halyard

Primary DI
10809160362211
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAPX012-05_0001
Catalog number
VAPX012-05
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10809160362211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916036221110809160362211

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). 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, 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160526156HALYARDPVHM204-02PVHM204-022026-07-06
10809160526484HalyardLANC009-34_0008LANC009-342026-07-06
10809160526491HalyardSGMN13-04_0011SGMN13-042026-07-06
10809160526507HalyardAVMD054_0002AVMD0542026-07-06
10809160526514HalyardSHAN446-04_0002SHAN446-042026-07-06
10809160526521HalyardONEL1180-04_0005ONEL1180-042026-07-06
10809160526545HalyardGBTJ22-02_0017GBTJ22-022026-07-06
10809160526798HalyardLIFE0242-02_0008LIFE0242-022026-07-06
10809160523063HalyardSFSLVTJ65-01_0001SFSLVTJ65-012026-06-09
10809160523070HalyardLVTJ65-01_0011LVTJ65-012026-06-09
10809160523087HalyardSFSMSBM022-06_0003SFSMSBM022-062026-06-09
10809160523094HalyardAXOG2000-11_0001AXOG2000-112026-06-09
10809160523100HalyardACTK56-03_0009ACTK56-032026-06-09
10809160523117HalyardSGGY67-05_0003SGGY67-052026-06-09
10809160523124HalyardBMHT020-05_0001BMHT020-052026-06-09
10809160523131HalyardSHAN409-06_0004SHAN409-062026-06-09
10809160523148HalyardAMCH001-02_0002AMCH001-022026-06-09
10809160523162HalyardDUCD44-03_0003DUCD44-032026-06-09
10809160523179HalyardLLHT24-01_0006LLHT24-012026-06-09
10809160523186HalyardLMCV54-01_0002LMCV54-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956488465CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956491922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956494794CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956496262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956497214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956502888CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956509443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956513891CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525016CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525207CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526815CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956527430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10809160526484HalyardAVID MEDICAL, INC.OEZ2026-07-06
10809160526514HalyardAVID MEDICAL, INC.OEZ2026-07-06
00884450423790Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-03
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09