Guardian

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: GUARDIAN FDA UDI
Generic Name: Suction system canister liner FDA UDI
Device Name: 2000 Guard I Kit W/5MM Tube W/O Vac Tube FDA UDI
Model / Reference: 65651-320 FDA UDI
Description: 2000 Guard I Kit W/5MM Tube W/O Vac Tube FDA UDI

Identifiers

Catalog Number: 65651-320 FDA UDI
Primary DI / UDI-DI: 50630140152595 FDA UDI
FDA Product Code: GCX FDA UDI
GMDN Term: Suction system canister liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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: Total Volume — 2000 Milliliter FDA UDI
Length — 6 Feet FDA UDI
Lumen/Inner Diameter — 0.19 Inch FDA UDI

Category: Suction system canister liner

Guardian by Cardinal Health 200, LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI 1f0051fd-d3a3-4287-9d8b-432337e7a885 35 fields · synced Jun 8, 2026