FDA.reportPublic FDA data

Argyle

Primary DI
10192253040296
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888160325
Catalog number
8888160325
Device description
"ArgylePolyurethane Umbilical Vessel CatheterSingle Lumen2.5 Fr/Ch(0.8 mm) x 9-8/10"""" (25 cm)0.16 mL Prime Volume"""
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
50192253040294PackageGS110In Commercial Distribution
10192253040296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304029450192253040294
1019225304029610192253040296

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 Gauge2.5French
Length9.8Inch
Total Volume0.16Milliliter

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

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
10192253040357ArgyleCardinal 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