AMIES AGAR CHARCOAL + SWAB, flocked tip, plast. stick
STD
STSSTRTUAMAC2
Valid Article
Account code:
60200
HS Code:
382200
Last Updated on:
07/11/2024, 16:27:24
Former
Code(s):
STSSTRTUAMS3
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).
20
Shelf life = length of time a product can remain active and effective.
Short shelf life = shelf life = < 24 months
A1102 - Sample collection swabs with transport medium
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
TRANSPORT MEDIUM AMIES AGAR CHARCOAL
Definition
Transport medium including sample collection swab allowing the preservation of aerobic/ anaerobic bacteria present in throat, wound, skin and vaginal samples.
Specifications
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Technical specifications
- Transport medium 5 ml: semi-solid agar, "Amies" with charcoal
- Sodium chloride: 3.00 g
- Distilled water: 1.00 liter
- Bacteriological agar: 7.50 g
- Charcoal: 10.00 g
- Sodium thioglycollate: 1.00 g
- Disodium phosphate: 1.15 g
- Monopotassium phosphate: 0.20 g
- Magnesium chloride: 0.10 g
- Calcium chloride: 0.10 g
- Potassium chloride: 0.20 g
- Transport tube
- clear PP
- Tube length 154.50 mm +/- 1.00 mm
- Insertion diameter 9.00 mm +/- 0.5 mm
- External diameter: 12.00 mm +/- 0.5 mm
- "Venturi" hour glass design to optimize moisture control
- White cap without receptacle
- external diameter : 12.00 mm +/- 0.10 mm
- Cap length : 32.80 mm ± 0.20 mm
- Insertion diameter : 9.00 mm +0.05 mm
- Material : high density polyethylene
- Swab: flocked rayon tip on plastic stick
- Applicator:
- total length : 147.00 mm ± 2.00 mm
- Stick diameter : 2.50 mm ± 0.10 mm
- Flocked length : 16.00 mm ± 3.00 mm
- Flocked diameter : 4.50 mm ± 0.50 mm
- Stick material: polystyrene
- Black Cap
- External cap diameter : 12.00 mm ± 0.10 mm
- Cap length : 32.80 mm ± 0.20 mm
- Insertion diameter : 9.30 mm + 0.05 mm
- Material: high density polyethylene
- Adhesive label
- Sterile, for single use
Packaging & Labelling
Individual peel off plastic pouch, 50 swabs / foil pack.
Instructions for use
Please consult the “Updated laboratory procedures, 2022” or “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/Home.aspx
For offline access, contact your laboratory advisor.
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Storage
- Between 5ºC and 25ºC. Do not freeze.
- Shelf life: ± 20 months
- Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
MSF requirements
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