FDA.reportPublic FDA data

Halyard

Primary DI
10809160532768
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BKAP27-03_0006
Catalog number
BKAP27-03
Published
2026-09-04
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
20809160532765PackageGS12In Commercial Distribution
10809160532768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053276520809160532765
1080916053276810809160532768

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
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532782HalyardKAFB008-10_0016KAFB008-102026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04
10809160532898HalyardEURO005-10_0004EURO005-102026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548497CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956549340CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956553217CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956558618CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956559684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956561861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562417CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956563704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956564848CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956566767CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956568457CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956569522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570535CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570573CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571570CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571884CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956572379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04