Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name: Epimed FDA UDI
Generic Name: Luer/Luer linear connector, single-use FDA UDI
Device Name: Nexus™ Small Bore Catheter Connector 21g FDA UDI
Model / Reference: 1911-421 FDA UDI
Description: Nexus™ Small Bore Catheter Connector 21g FDA UDI

Identifiers

Catalog Number: 1911-421 FDA UDI
Primary DI / UDI-DI: 00818788023582 FDA UDI
510(k) Number: K051171 FDA UDI
FDA Product Code: CAZ FDA UDI
GMDN Term: Luer/Luer linear connector, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5140 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Luer/Luer linear connector, single-use

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

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Cleared under the same submission

K051171 also covers:

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: Epimed International, Inc.

Sources (1)

FDA UDI 7bc57b8a-1860-4223-9810-e2c502fd1436 37 fields · synced Jun 4, 2026