FDA.reportPublic FDA data

HALYARD

Primary DI
10809160539132
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
BPAT45-02
Catalog number
BPAT45-02
Published
2026-09-28
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160539139PackageGS14In Commercial Distribution
10809160539132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053913920809160539139
1080916053913210809160539132

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596597CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956598188CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
00884450436004Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-29
10198956540491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956542136CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580770CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580978CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956589988CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590625CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590953CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
B098AMS194890Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-09-29
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956583931CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25