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Argyle

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Argyle FDA UDI
Generic Name
Peripheral intravenous catheterization kit, non-sensing FDA UDI
Device Name
Peripheral Inserted Central Catheter (PICC) Insertion Tray,Dual Lumen FDA UDI
Model / Reference
43311 FDA UDI
Description
Peripheral Inserted Central Catheter (PICC) Insertion Tray,Dual Lumen FDA UDI

Identifiers

Catalog Number
43311 FDA UDI
Primary DI / UDI-DI
10884521743755 FDA UDI
FDA Product Code
OWL FDA UDI
GMDN Term
Peripheral intravenous catheterization kit, non-sensing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 30 Centimeter FDA UDI
Catheter Gauge — 1.9 French FDA UDI

Category: Peripheral intravenous catheterization kit, non-sensing

Argyle by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral intravenous catheterization kit, non-sensing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 33a71e35-0bdb-4c26-9df7-535587b6475a 37 fields · synced May 30, 2026