FDA.reportPublic FDA data

Halyard

Primary DI
10809160538616
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
HVBM201-06_0005
Catalog number
HVBM201-06
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
10809160538616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053861610809160538616

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
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
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22
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