XO Cath E20-130-S

GUDID B090E20130S1

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.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular microcatheter
Primary Device IDB090E20130S1
NIH Device Record Key51e709ac-971a-485a-b5c1-436290881f74
Commercial Distribution StatusIn Commercial Distribution
Brand NameXO Cath
Version Model NumberE20-130-S
Catalog NumberE20-130-S
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French
Catheter Length130 Centimeter
Catheter Gauge2 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090E20130S0 [Primary]
HIBCCB090E20130S1 [Package]
Contains: B090E20130S0
Package: Shelf Carton [1 Units]
In Commercial Distribution
HIBCCB090E20130S2 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

On-Brand Devices [XO Cath]

B090E20130S1The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used
B090E20130B1The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used

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