BLOOD CULTURE AEROBIC NEONAT., 9ml,bot [Liofilchem-490050]

STD SBCMRDTUBAELN

Valid Article

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).
Article is intended to be used with children (<12 years) ONLY.
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.
W0104010501 - Bottles for manual blood culture
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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BLOOD CULTURE AEROBIC BOTTLE (manual)

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CAUTION

This item is worded and codified by unit to make the order easier, but is always packaged in kit of 6 bottles.

Definition

The bottles HEMO-AEROBIC CULTURING contain a very nutritive medium, a Brain Heart Infusion Broth (B.H.I.) with p- Aminobenzoic Acid (PABA) and Sodium-polyanethol-sulphonate (SPS) for culturing fastidious, aerobic and facultative anaerobic, microorganisms from venous blood.

In addition to blood culture, it can also be used for the culture of bones and tissues.

Specifications

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Components

Culture Medium Formula:

  • Brain heart infusion 17 g/l
  • Peptone 10 g/l
  • Dextrose 2 g/l
  • Sodium chloride 5 g/l
  • Sodium phosphate bibasic 2.5 g/l
  • p- Aminobenzoic acid 0.05 g/l
  • Sodium-polyanethol-sulphonate 0.3 g/l

Technical specifications

The bottle is endowed with a plastic green cap, a perforable rubber subcap, and a transparent protective cap for 80 and 40 ml bottles.

The bottle for neonatal use is endowed with a grey perforable rubber stopper and a metallic screw cap with a green lift plastic overcap.

Volume of blood to be added:

  • for adult: 8 to 10 ml
  • child: 4 to 5 ml
  • neonate: 0.5 to 1 ml

Packaging & Labelling

  • 490010: 6 bottles with 80 ml of Brain Heart Infusion Broth + PABA + SPS
  • 490030: 6 bottles with 40 ml of Brain Heart Infusion Broth + PABA + SPS
  • 490050: 6 bottles with 9 ml of Brain Heart Infusion Broth + PABA + SPS
  • 1 instruction sheet in each package

Instructions for use

Follow the package insert recommendations.

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 10°C and 25°C
  • Keep away from sources of heat
  • Avoid excessive changes in temperatures
  • Do not use after expiry date
  • Shelf life: 24 months

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilize the cultures and all contaminated material. Please contact your watsan referent for advice on proper disposal.

MSF requirements

Reserved to bacteriology programmes.

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