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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Catheter care kit FDA UDI
Device Name
CATHETER,URETHRAL,REDRUBBER,COUDE,14FR FDA UDI
Model / Reference
DYND13614 FDA UDI
Description
CATHETER,URETHRAL,REDRUBBER,COUDE,14FR FDA UDI

Identifiers

Catalog Number
DYND13614 FDA UDI
Primary DI / UDI-DI
10080196031276 FDA UDI
FDA Product Code
KOD FDA UDI
GMDN Term
Catheter care kit 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: Catheter care kit

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter care kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI f01f43b1-521a-4b82-a511-9743115508f9 36 fields · synced May 31, 2026