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Argyle

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Argyle FDA UDI
Generic Name
Umbilical catheter FDA UDI
Device Name
Argyle Polyurethane Umbilical Vessel Catheter Triple Lumen 8 Fr/Ch (2.7 mm) x 9-8/10"" (25 cm) 15/18/18 G (1.8/1.3/1.3 mm) 0.77 mL, 0.33 mL, 0.33 mL" FDA UDI
Model / Reference
8888160663 FDA UDI
Description
Argyle Polyurethane Umbilical Vessel Catheter Triple Lumen 8 Fr/Ch (2.7 mm) x 9-8/10"" (25 cm) 15/18/18 G (1.8/1.3/1.3 mm) 0.77 mL, 0.33 mL, 0.33 mL" FDA UDI

Identifiers

Catalog Number
8888160663 FDA UDI
Primary DI / UDI-DI
10192253040388 FDA UDI
FDA Product Code
FOS FDA UDI
GMDN Term
Umbilical catheter 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

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 — 9.8 Inch FDA UDI
Catheter Gauge — 8 French FDA UDI

Category: Umbilical catheter

Argyle by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Umbilical catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI b56839ee-90f0-40b2-bb61-29a759e1cc01 35 fields · synced Jun 8, 2026