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Dover

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Dover FDA UDI
Generic Name
Single-administration urethral drainage/irrigation catheter FDA UDI
Device Name
SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 30 CC, 3-WAY, 16 FR (5.3 MM) FDA UDI
Model / Reference
8887689167 FDA UDI
Description
SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 30 CC, 3-WAY, 16 FR (5.3 MM) FDA UDI

Identifiers

Catalog Number
8887689167 FDA UDI
Primary DI / UDI-DI
10192253027105 FDA UDI
FDA Product Code
KOD FDA UDI
GMDN Term
Single-administration urethral drainage/irrigation catheter 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

No

FDA UDI

Contains Latex

Yes

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

Category: Single-administration urethral drainage/irrigation catheter

The Dover catheter is a sterile, flexible tube designed to provide one episode of irrigation and/or drainage of the bladder. This single-use device is typically inserted through the urethra and into the urinary bladder by a healthcare professional. It features a silicone elastomer coating for long-term durability.

Similar devices

Also classified as Single-administration urethral drainage/irrigation 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 e6ba8c0d-ff7c-4f95-a6e2-684351e6084a 34 fields · synced Jul 25, 2026