FDA.reportPublic FDA data

Halyard

Primary DI
10809160537138
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
LATH030-01
Published
2026-09-18
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
20809160537135PackageGS15In Commercial Distribution
10809160537138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053713520809160537135
1080916053713810809160537138

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
092364462
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
10809160539019Medical Action Industries83989B2026-09-25
10809160539026HalyardDNAZ037-032026-09-25
10809160535523HalyardLLOF3100-022026-09-24
10809160538913HalyardMHSH2002-012026-09-24
10809160538937HalyardAXOG2000-122026-09-24
10809160538968HalyardDNAZ034-032026-09-24
10809160538999HalyardLLOF006-012026-09-24
10809160536889HalyardMEPK70E-012026-09-22
10809160538579HalyardVMED013-062026-09-22
10809160538609HalyardLH_267001_B12026-09-22
10809160538326HalyardSLNC22-022026-09-21
10809160538333HalyardBHPK801-012026-09-21
10809160538340HalyardASLH9728-012026-09-21
10809160538357HalyardBUFF100-032026-09-21
10809160538364HalyardGTMO010-052026-09-21
10809160538371HalyardMISS803-032026-09-21
10809160538388HalyardDONS108-022026-09-21
10809160538395HalyardSILV800-022026-09-21
10809160538401HalyardKOOT800-022026-09-21
10809160538418HalyardSAMR9825-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956586208CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956587342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588691CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588882CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588998CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589230CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589421CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956592605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956339255CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956504271CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956577664CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582149CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22