KOLMI - Op Air One Medical Mask

Medical device : Class 1

Medical mask with ties-on and anti-fog band - Type IIR - MD Class 1 - Made in France

Ref.M34101F-30


  • Dental

  • Medical

  • Industry

  • Hygiene
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KOLMI - Op Air One Medical Mask

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FEATURES AND BENEFITS

TECHNICAL DESCRIPTION

PRODUCT INFORMATIONS

Features and benefits

KOLMI LOGO

KOLMI OP AIR ONE

 

  • Prevents glasses from fogging up 
  • Respect for the wearer's skin (absorption of sweat and condensation)
  • Exceptional respiratory comfort
  • This product is a CE medical device

Technical description

  • Type of coverage : Type IIR
  • Size / Dimensions : 95 x 175 mm (± 5 mm)
  • Type of fasteners : Straps
  • Use : Medical
  • Made in : France
  • ce CE
  • 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
  • Complies with the requirements of European Regulation 2017 745 relating to Medical Devices
  • EN 14683 : 2019 + AC: 2019
  • Evaluation of microbial contamination according to ISO 11737 : 2018 + A1 : 2021
  • Clean room ISO 8 production
  • ISO 10993-5
  • ISO 10993-10

Product features

Brand Article Size Colour
Kolmi M34101F-30 95 x 175 mm Blue
Kolmi M34301F-30 95 x 175 mm Honeycomb

Packaging Features

Sub packaging Packaging
Dispenser box 6 x 40
Dispenser box 6 x 40

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