FDA.report

Argyle

Primary DI
10884527005185
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888160556
Catalog number
8888160556
Device description
Polyurethane Umbilical Vessel Catheter,Dual 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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FOSCATHETER, UMBILICAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
FOSCatheter, Umbilical ArteryGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884527005185PackageGS15In Commercial Distribution
20884527005182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452700518510884527005185
2088452700518220884527005182

GMDN Terms

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

TypeValueUnit
Catheter Gauge5French
Device Size Text, specify0
Length9.8Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Contacts

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 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 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