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(clinical chemistry i-STAT) CARTRIDGE PTPlus, 03P89-50

https://unicat.msf.org/cat/product/96428
NST ELAECCHT138

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
W0103020801 - Prothrombin time RT & POC
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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)
https://unicat.msf.org/web/image/product.template/587906/image_1920?unique=2a6e301

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(clinical chemistry i-STAT) CARTRIDGE PT Plus

This cartridge is replacing ELAECCHT107 which will no longer be recognized by the software after the May 2025 update.

ELAECCHT138 requires a software update, please contact your OC's Biomed advisor for support.

CAUTION

This item is worded and codified by unit to make the order easy but is always packaged in kit of 25.

Definition

The i-STAT PT Plus cartridge enables measurement of prothrombin time (PT) and international normalized ratio (INR)

These cartridged are used to monitor the risk of bleeding or clotting.

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
  • Sample volume: 20 µl
  • Sample type: capillary or veinous whole blood
  • Analyse time: 5 minutes
  • Measurable ranges:
    • PT: 8.1 - 80.8 sec
    • INR: 0.8 - 8.0

Dimensions

  • Box: 20 (L) x 7 (H) x 9.7 cm (P)
  • Cartridge package: 6.7 (H) x 9.5 cm (L)

Packaging & Labelling

Box of 25 cartridges, in individual pouch

To be Ordered Separately

Control solutions (see related items)

Instructions for use

Follow the instructions manual.

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Storage

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 6 months
  • Cartridges could be stored between 18 and 30°C during 14 days
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

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Description validated by the OCB referent (Pascale Chaillet) in April 2025