KOLMI - Op Air Pro Oxygen Mask

Medical device : Class 1
Personal protective equipment : Category 3

Respiratory protective mask with headloops - FFP1 NR D - Type IIR - MD Class 1 - PPE Cat III - Made in France

Ref.M51010S-WH


  • Dental

  • Medical

  • Industry

  • Hygiene
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KOLMI Op Air Pro Oxygen Mask

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FEATURES AND BENEFITS

TECHNICAL DESCRIPTION

PRODUCT INFORMATIONS

Features and advantages

Kolmi  KOLMI OP AIR PRO OXYGEN

  • Comfortable thanks to its shape and the use of soft & smooth materials
  • Exceptional breathability
  • Perfect fit to the wearer's face
  • This product is an CE device, certified by notified body n°0082

Technical description

  • Type of coverage : Type IIR FFP1
  • Size / Dimensions : 90 x 240 mm (± 3 mm)
  • Type of fasteners : Transverse elastics
  • Use : Medical and Respiratory Protection (FFP)
  • Made in : France
  • unsterile Unsterile
  • single-use Single-use
  • without-latex Without Latex
  • should-not-be-stuck-in-a-damp-place Should not be stuck in a damp place
  • should-not-be-exposed-to-temperature-variations-above-or-below Should not be exposed to temperature variations above or below
  • must-not-be-exposed-to-the-sun Must not be exposed to the sun
  • do-not-use-if-the-packaging-is-damaged Do not use if the packaging is damaged
  • dispositif-mdical Dispositif médical

Product informations

Certifications and standards :

  • Manufactured under a certified quality system ISO 13485
  • Manufactured under a certified quality system ISO 9001
  • EN 149 :2001+A1 :2009 standard
  • Complies with the requirements of European Regulation 2017 745 relating to Medical Devices
  • EN 14683 : 2019 + AC: 2019
  • Compliant EU Regulation 2016/425 on Personal Protective Equipment
  • Evaluation of microbial contamination according to ISO 11737 : 2018 + A1 : 2021
  • ISO 10993-5
  • ISO 10993-10

Product features

Brand Article Size Colour
Kolmi M51010S-WH 90 x 240 mm White

Packaging Features

Sub packaging Packaging
Dispenser box 10 x 50

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