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EMBOLECTOMY CATHETER, CH 4, balloon, 80 cm, ster., s.u.

https://msf.oodin.sh/cat/product/45058
NST SINSEMBC480

Valid Article

Former Code(s): SCTDEMBC4FR SCTDZBD0016 SCTDZBE0084 SCTDZNL0053 SCTDFOTC480 SINSEMBC4--
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
C019002 - Embolectomy catheters
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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THROMBECTOMY BALLOON CATHETER

Definition

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device

Synonym

FOGARTY catheter, embolectomy catheter

Specifications

Technical specifications

  • Material: polyurethane shaft
  • radio-opaque
  • single-lumen
  • graded every 5 - 10 cm
  • length 60 - 80 cm
  • CH 2 - CH 8
  • colour coded catheter and balloon capacity size
  • Proximal end: transparent Luer lock tip, with screw cap
  • Distal end: short atraumatic tip with strong cylinder shaped latex balloon
  • With rigid stylet in stainless steel
  • Sterile, for single use,
  • Single unit sealed packaging,

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Instructions for use

A method of arterial clearing of introducing into the artery, upstream of the obliterated area, a probe provided with a balloon at its end. The probe is pushed as far as possible downstream of the obstruction with a flat balloon is and then removed, then the balloon is inflated, so as to bring clots and loosened thrombi.

MSF requirements

Used in vascular operations to clear the arterial system.

  • all orders have to be cleared by the surgical and anasthesia referent, and by the OC MedDir.
  • OCP: temporary validation for Haiti, Yemen and Syria
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