Qitexio 4-Way Stopcock

FDA UDI

Class II (US FDA UDI)

by Medex, Inc.

Identity

Trade Name: Qitexio 4-Way Stopcock FDA UDI
Generic Name: Stopcock FDA UDI
Device Name: Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery. FDA UDI
Model / Reference: QIT014 FDA UDI
Description: Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery. FDA UDI

Identifiers

Primary DI / UDI-DI: 23700550400763 FDA UDI
510(k) Number: K242255 FDA UDI
FDA Product Code: FMG FDA UDI
GMDN Term: Stopcock 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

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

MRI Safety

MR Safe FDA UDI

Category: Stopcock

Qitexio 4-Way Stopcock by Medex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Medex, Inc.

Sources (1)

FDA UDI 2a0f0416-881e-4847-9d35-48f996d41979 37 fields · synced May 30, 2026