Dover

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Dover FDA UDI
Generic Name: Indwelling urethral catheterization kit, adult FDA UDI
Device Name: HYDROGEL COATED COUDE TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG FDA UDI
Model / Reference: 7016C FDA UDI
Description: HYDROGEL COATED COUDE TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG FDA UDI

Identifiers

Catalog Number: 7016C- FDA UDI
Primary DI / UDI-DI: 10192253031539 FDA UDI
FDA Product Code: PPG FDA UDI
GMDN Term: Indwelling urethral catheterization kit, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

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

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Also classified as Indwelling urethral catheterization kit, adult.

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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 f9c84580-dccc-40c7-9906-87a3df184ac6 36 fields · synced Jun 8, 2026