Qitexio 4-Way Stopcock

GUDID 33700550400760

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.

MEDEX

Stopcock

• Primary Device ID: 33700550400760
• NIH Device Record Key: 2a0f0416-881e-4847-9d35-48f996d41979
• Commercial Distribution Discontinuation: 2999-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qitexio 4-Way Stopcock
• Version Model Number: QIT014
• Company DUNS: 398197913
• Company Name: MEDEX
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com
• Phone: 1-877-729-6679
• Email: customer.service-us@guerbet.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700550400766 [Unit of Use]
GS1	23700550400763 [Primary]
GS1	33700550400760 [Package]; Contains: 23700550400763; Package: Carton [6 Units]; Discontinued: 2999-12-31; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242255

FDA Product Code

• FMG: Stopcock, I.V. Set

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by MEDEX

• 33700550400760 - Qitexio 4-Way Stopcock: 2025-05-19Qitexio(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.
• 33700550400760 - Qitexio 4-Way Stopcock: 2025-05-19 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
• 13700550400971 - Qitexio Luer Lock Syringe 20mL: 2024-12-31
• 33700550400739 - Qitexio: 2022-10-21 1 ml Luer Lock Syringe
• 33700550400746 - Qitexio: 2022-10-21 3 ml Luer Lock Syringe