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(Densimat) CONTROL KIT [BMX-15512]

https://unicat.msf.org/cat/product/45324
NST ELAEDENC112

Valid Article

Former Code(s): SLASZBD0252
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.
11
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
P
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
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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(Densimat) CONTROL KIT

Definition

The ATB densitometer control kit is designed to test densitometers from Densimat.

Regular use of the kit enables the accuracy of the instrument to be monitored and therefore the quality of the inoculum to be controlled.

Specifications

The kit consists of several ampules enabling the testing of the entire reading scale of the instrument.

Each ampule has a reference (number) and its true value, expressed in the 2 units used [McFarland (McF) and number of diodes], is printed on the label.

By simply placing these ampules in the densitometer one at a time, the value indicated by the instrument can be compared to the value printed on the ampule label.

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Components

Medium composed by demineralized water, gelling agent, latex and Ca++.

Technical specifications

  • Do not open the ampules.
  • Do not shake the ampules.

Packaging & Labelling

Kit of 5 ampules:

  • 1 ampule 0 McF
  • 1 ampule 0.5 McF
  • 1 ampule 3 McF
  • 1 ampule 6 McF
  • 1 ampule > 7.5 McF

And one package insert.

Transport Dangerous Goods

Transport not regulated

To be Ordered Separately

  • Swabs
  • Alcohol (90°)
  • Cleaning device (Ref. 4550409A)
  • Fluffless cloth.

Instructions for use

  • It is recommended to test the accuracy of the densitometers once a month.
  • Before testing the instrument, it must be cleaned.
  • Each ampule should be wiped clean with a dry, fluffless cloth prior to use.
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Storage

  • Store between 15 and 25°C.
  • Do not freeze.
  • Do not use after expiry date.
  • Shelf life: 11 month.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.

(Cf Introduction: Thermosensitive products)

Classification EC Regulation N° 1272/2008

Not classified as hazardous

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