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: 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD FDA UDI
Model / Reference: P4P16XTSD FDA UDI
Description: 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD FDA UDI

Identifiers

Catalog Number: P4P16XTSD- FDA UDI
Primary DI / UDI-DI: 10192253031874 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Total Volume — 400 Milliliter FDA UDI
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

Dover is a high-quality, FDA-registered indwelling urethral catheterization kit designed for urinary drainage from the bladder of adults and children. This single-use device features a silicone silver-hydrogenate coating, allowing for precise temperature sensing. The catheter has a flexible design with a 16Fr gauge and is available in two sizes, including a Total Volume unit of 400ml and a French gauge of 16.

Similar devices

Also classified as Indwelling urethral catheterization kit, adult.

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Dover — Cardinalhealth · Class II
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Dover — Cardinalhealth · Class II
NURSE ASSIST — NURSE ASSIST, INC. · Class II
Bardex® I.C. Foley Catheter Tray — C. R. Bard, Inc. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II

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 2f8676ce-f2d4-44dd-9a4a-f047243cdd0b 36 fields · synced Oct 6, 2026