AccessGUDID - DEVICE: Qitexio 4-Way Stopcock (23700550400763)

GUDID

Device Identifier (DI) Information

Brand Name: Qitexio 4-Way Stopcock
Version or Model: QIT014
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDEX

Primary DI Number: 23700550400763
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2999
Device Count: 5
Labeler D-U-N-S® Number*: 398197913 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMG	Stopcock, I.V. Set

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242255	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a0f0416-881e-4847-9d35-48f996d41979
Public Version Date: May 19, 2025
Public Version Number: 1
DI Record Publish Date: May 09, 2025