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(clinical chem. i-STAT)CARTRIDGE COAGULATION PT/INR 03P89-24

https://unicat.msf.org/cat/product/13254
STD ELAECCHT107

Valid Article

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.
6
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010404 - Multiple parameters (mix of all) - clin. chem lab r.
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.
0208
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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(clinical chemistry i-STAT) CARTRIDGE PT/INR

Definition

Single use cartridges to be used with the i-STAT for a whole blood determination of the prothrombin time (PT/INR), used for monitoring oral anticoagulant (warfarin therapy).

Specifications

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Technical specifications

  • Parameters determined: PT/INR. The prothrombine time test result is reported as an International Normalized Ratio (INR)
  • 1 cartridge is aimed to perform the tests for 1 patient
  • Controls should be ordered separately

Packaging & Labelling

Box of 25 cartridges

Instructions for use

Follow the instructions manual

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Storage

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 6 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

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