FDA.reportPublic FDA data

Argyle

Primary DI
10192253040357
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888160531
Catalog number
8888160531
Device description
"ArgylePolyurethane Umbilical Vessel CatheterDual Lumen3.5 Fr/Ch(1.2 mm) x 9-8/10"""" (25 cm)20/23 G (0.9/0.6 mm)0.21 mL, 0.16 mL"""
Published
2024-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOSCATHETER, UMBILICAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOSCatheter, Umbilical ArteryGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253040355PackageGS15In Commercial Distribution
10192253040357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304035550192253040355
1019225304035710192253040357

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical catheterA very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3.5French
Length9.8Inch

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040203ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040210ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040289ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040326ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040333ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040340ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040395ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040401ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040201ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040218ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040287ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040324ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040331ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040348ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040393ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040409ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040296ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040294ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040355ArgyleCardinal Health 200, LLCFOS2024-10-16
10192253040388ArgyleCardinal Health 200, LLCFOS2024-09-30
50192253040386ArgyleCardinal Health 200, LLCFOS2024-09-30
10192253040371ArgyleCardinal Health 200, LLCFOS2024-08-23
50192253040379ArgyleCardinal Health 200, LLCFOS2024-08-23
10192253040364ArgyleCardinal Health 200, LLCFOS2024-07-12
50192253040362ArgyleCardinal Health 200, LLCFOS2024-07-12
10192253040302ArgyleCardinal Health 200, LLCFOS2024-06-20
50192253040300ArgyleCardinal Health 200, LLCFOS2024-06-20
10192253040319ArgyleCardinal Health 200, LLCFOS2024-06-06
50192253040317ArgyleCardinal Health 200, LLCFOS2024-06-06
03660812129664VYGONVYGONFOS2023-07-25