FDA.report

Argyle

Primary DI
50192253040294
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888160325
Catalog number
8888160325
Device description
Argyle Polyurethane Umbilical Vessel Catheter Single Lumen 2.5 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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FOSCATHETER, UMBILICAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
FOSCatheter, Umbilical ArteryGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253040294PackageGS110In Commercial Distribution
10192253040296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225304029450192253040294
1019225304029610192253040296

GMDN Terms

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

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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