(clinical chem. i-STAT) CARTRIDGE CHEM 8+ ref.09P31-25

STD ELAECCHT106

Valid Article

Former Code(s): DDGTANAL106
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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 CHEM8+

CAUTION

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

Definition

Single use cartridges to be used with the i-STAT for quantitative determination of clinical chemistry parameters, with arterial or venous whole blood.

Specifications

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Technical specifications

  • Chemistry parameters determined:
    • Sodium (Na)
    • Potassium (K)
    • Chloride (Cl)
    • Ionized Calcium (iCa)
    • TCO2
    • Glucose (Glu)
    • Urea Nitrogen / (BUN) / Urea
    • Creatinine (Crea)
    • Haematocrit (Hct)
    • Haemoglobin (Hgb)
    • Anion gap
  • 1 cartridge is aimed to perform the tests for 1 patient

Packaging & Labelling

Box of 25 cartridges

To be Ordered Separately

  • Control solutions: level 1, 2 and 3 (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.

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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