AccessGUDID - DEVICE: XO Cath (B090E20130S0)

GUDID

Device Identifier (DI) Information

Brand Name: XO Cath
Version or Model: E20-130-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E20-130-S
Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.

Primary DI Number: B090E20130S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017535668 *Terms of Use

Device Description: The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRA	Catheter, Continuous Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 130 Centimeter
Catheter Gauge: 2 French

Device Record Status

Public Device Record Key: 51e709ac-971a-485a-b5c1-436290881f74
Public Version Date: May 08, 2024
Public Version Number: 1
DI Record Publish Date: April 30, 2024