FDA.reportPublic FDA data

Argyle

Primary DI
10884521070370
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888160226
Catalog number
8888160226
Device description
PVC Umbilical Vessel Catheter,Single Lumen
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
20884521070377PackageGS110In Commercial Distribution
10884521070370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452107037720884521070377
1088452107037010884521070370

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular catheterA sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length16Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

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
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

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