Qitexio 4-Way Stopcock

Basic Information

• Brand Name: Qitexio 4-Way Stopcock
• Primary DI: 23700550400763
• Version / Model: QIT014
• Company Name: MEDEX
• Labeler DUNS: 398197913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-05-09
• Public Version: 1
• Public Version Date: 2025-05-19
• Public Version Status: New
• Public Device Record Key: 2a0f0416-881e-4847-9d35-48f996d41979
• Distribution End Date: 2999-12-31

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMG	Stopcock, I.V. Set	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	33700550400760	GS1	Carton	6	In Commercial Distribution	2999-12-31
Primary	23700550400763	GS1
Unit of Use	13700550400766	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242255	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius