Home GUDID 00818053022982 ECLIPSE 2L
Primary DI 00818053022982
Brand ECLIPSE 2L
Company BALT USA LLC
Model ECL2L6x15
Catalog number N/A
Device description ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation and deflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
Published 2019-07-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name DQY Catheter, Percutaneous MJN Catheter, Intravascular Occluding, Temporary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 MJN Catheter, Intravascular Occluding, Temporary Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00818053022982 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00818053022982 00818053022982 818053022982 0818053022982
GMDN Terms# Term, Definition table Term Definition Intravascular occluding balloon catheter, image-guided A flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Inner Diameter 0.016 Inch Length 160 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry place at room temperature and away from light
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