Argyle

Primary DI
50192253040331
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888160424
Catalog number
8888160424
Device description
Polyurethane Umbilical Vessel Catheter Insertion Tray
Published
2025-01-08
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
50192253040331PackageGS15In Commercial Distribution
10192253040333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225304033150192253040331
1019225304033310192253040333

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge3.5French

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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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