FDA.reportPublic FDA data

Argyle

Primary DI
20884527005113
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888160333
Catalog number
8888160333
Device description
Polyurethane Umbilical Vessel Catheter,Single Lumen
Published
2016-10-14
Public version status
Update
Distribution status
Not 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
10884527005116PackageGS110Not in Commercial Distribution
20884527005113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700511610884527005116
2088452700511320884527005113

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
Total Volume0.15Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

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
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