FDA.reportPublic FDA data

Argyle

Primary DI
10884527005123
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888160341
Catalog number
8888160341
Device description
Polyurethane Umbilical Vessel Catheter,Single Lumen
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10884527005123PackageGS110In Commercial Distribution
20884527005120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700512310884527005123
2088452700512020884527005120

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
Length9.8Inch
Total Volume0.33Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
50192253040294ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040355ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040386ArgyleCardinal Health 200, LLCFOS2024-09-30
50192253040379ArgyleCardinal Health 200, LLCFOS2024-08-23
50192253040362ArgyleCardinal Health 200, LLCFOS2024-07-12
50192253040300ArgyleCardinal Health 200, LLCFOS2024-06-20
50192253040317ArgyleCardinal Health 200, LLCFOS2024-06-06
53660812129669VYGONVYGONFOS2023-07-25
33660812128576VYGONVYGONFOS2023-07-21
33660812128774VYGONVYGONFOS2022-06-09
33660812128552VYGONVYGONFOS2022-04-21
33660812128569VYGONVYGONFOS2022-04-21
53660812128693VYGONVYGONFOS2022-04-21
53660812128709VYGONVYGONFOS2022-04-21
53660812128839VYGONVYGONFOS2022-04-21
33660812128903VYGONVYGONFOS2021-08-06
33660812129603VYGONVYGONFOS2021-08-06
33660812129610VYGONVYGONFOS2021-08-06
53660812130191VYGONVYGONFOS2021-08-06
33660812130890VYGONVYGONFOS2021-08-06
53660812130900VYGONVYGONFOS2021-08-06
10884527005109ArgyleCardinal Health, Inc.FOS2016-10-14