Luther Needlesafe Products

FDA UDI

Class II (US FDA UDI)

by Luther Needlesafe Products, Inc.

Identity

Trade Name: Luther Needlesafe Products FDA UDI
Generic Name: Peripheral intravenous cannula FDA UDI
Device Name: Mini-Midline Extended Dwell Peripheral Catheter - 18Ga, 1.75” FDA UDI
Model / Reference: 18175001 FDA UDI
Description: Mini-Midline Extended Dwell Peripheral Catheter - 18Ga, 1.75” FDA UDI

Identifiers

Catalog Number: 18175001 FDA UDI
Primary DI / UDI-DI: 00850017259003 FDA UDI
510(k) Number: K130518 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Peripheral intravenous cannula FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 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

Category: Peripheral intravenous cannula

Luther Needlesafe Products by Luther Needlesafe Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Peripheral intravenous cannula.

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McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Navilyst Medical — NAVILYST MEDICAL, INC.
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II

Cleared under the same submission

K130518 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: Luther Needlesafe Products, Inc.

Sources (1)

FDA UDI 8e419380-6c72-4ccd-8673-dd3e22345e91 35 fields · synced May 30, 2026