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M33101-40_en_GB_TECHNICAL_DATA_SHEET

M33101-40_en_GB_TECHNICAL_DATA_SHEET

M33101-40_en_GB_TECHNICAL_DATA_SHEET

Product catalog summary
Features & Benefits:
  • Environmental protection from droplets and biological fluid splashes.
  • Effective against bacteria, particles, and viruses with tested BFE, PFE, and VFE.
  • Origami folding for comfort and fit.
  • Hypoallergenic material.
Product Details:
  • Name: Kolmi Vitals
  • Type: Single use, non-sterile
  • Fasteners: Ties-on
  • Nose piece: Polypropylene and metal
  • Color: Blue
  • Quantity per box: 50 units
  • Size: 175 x 95 mm
  • Unit weight: 4.4 g
  • Origin: France
Recommended Use:
  • For medical staff and operating room use.
  • Suitable for patients to reduce infection spread.
  • Usage should not exceed 4 hours.
Compliance & Standards:
  • Complies with EN 14683:2019+AC:2019.
  • Meets Regulation (EU) 2017/745 on medical devices.
  • Manufacturing site certified ISO 9001 and ISO 13485.
Microbiological Information:
  • Initial microbial contamination assessed per EN 14683:2019+AC:2019 and ISO 11737:2018+A1:2021.
  • Additional controls for ASR, E.coli, Staphylococci available upon request.
Precautions:
  • Use on intact skin only.
  • Reuse or extended use may cause infection or cross-contamination.
  • Follow national legislation for disposal.
Storage:
  • Store at room temperature, away from moisture and sunlight.
  • Shelf life: 5 years.
Packaging & Logistics:
  • Outer case size: 400 x 400 x 180 mm, weight: 1.8 kg, 60 cases per pallet.
  • Inner box size: 211 x 97 x 97 mm, weight: 265 g, contains 6 x 50 units.
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Catalog excerpts

M33101-40_en_GB_TECHNICAL_DATA_SHEET-1

Medical Device Class 1 FEATURES & BENEFITS • Protects the environment from droplets emitted by the wearer while providing protection from splashes of biological fluids. • Effective against bacterias, particles and viruses (BFE, PFE, & VFE tested). • Kolmi masks feature the exclusive Origami folding for greater comfort and a perfect fit on the wearer's face. RECOMMENDED USE Use by medical staff. Use by operating room staff in surgeries where there is a risk of splashing of biological fluids. Medical face masks may also be intended to be worn by patients and others to reduce the risk of spreading infection, particularly in epidemic or pandemic situations. Wearing the mask should not exceed 4 hours Inner layer: Outer layer: Splash barrier: Filter media: Nose piece: Ties-on: PRODUCT DETAILS Product name : Product type : Nose piece : Unit weight: Kolmi Vitals Single use, non sterile Ties-on spunbond polypropylene spunbond polypropylene spunbond polypropylene meltblown polypropylene polypropylene + metal spunbond polypropylene COMPLY WITH STANDARD EN 14683:2019+AC:2019 TEST

 Open the catalog to page 1
M33101-40_en_GB_TECHNICAL_DATA_SHEET-2

Assessment of initial microbial contamination according to standards EN 14683: 2019+AC:2019 and ISO 11737:2018+A1:2021. Additional microbiological controls: ASR, E.coli, Staphylococci, available upon request. • Meet the requirements of Regulation (EU) 2017/745 on medical devices. • Complies with applicable standards EN 14683: 2019 + AC:2019. The mask must be used on intact skin only. The reuse or extended use may lead to infection or cross-contamination. Please refer to your national legislation on the subject of disposal of this product once it has been used. Normal storage conditions : should...

 Open the catalog to page 2
*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.