DualCap®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: DualCap® FDA UDI
Generic Name: Luer-formatted disinfection cap FDA UDI
Model / Reference: 10884450309367 FDA UDI

Identifiers

Catalog Number: 500-LB/A FDA UDI
Primary DI / UDI-DI: 10884450309367 FDA UDI
FDA Product Code: QBP FDA UDI
GMDN Term: Luer-formatted disinfection cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Category: Luer-formatted disinfection cap

A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection.

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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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 21fe81cf-0658-4e15-84e7-b90bb21e981c 33 fields · synced Jul 25, 2026