Argyle

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Argyle FDA UDI
Generic Name: Sump drain FDA UDI
Device Name: Argyle Saratoga Sump Drain 28 Fr/Ch (9.3 mm) x 20” (51 cm) FDA UDI
Model / Reference: 8888531046 FDA UDI
Description: Argyle Saratoga Sump Drain 28 Fr/Ch (9.3 mm) x 20” (51 cm) FDA UDI

Identifiers

Catalog Number: 8888531046 FDA UDI
Primary DI / UDI-DI: 10192253003451 FDA UDI
FDA Product Code: GEA FDA UDI
GMDN Term: Sump drain FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 20 Inch FDA UDI
Catheter Gauge — 28 French FDA UDI

Category: Sump drain

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI 73ce25da-63d5-4824-8456-c94ae0651853 35 fields · synced Jun 8, 2026