Intended purpose of use: for reliable site preparation for injections, other laboratory and household uses.
Product description:
Swab with 70% v/v isopropyl alcohol solution.
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Minimum 4 log reduction for disinfection purpose.
Instructions for use:
Alcohol Swabs help fight bacterial and cleanse the skin. To be used when prepping the skin for an injection, as well as cleaning wounds before bandaging. Intended use, warnings, storage instructions and disposal instructions shall be provided.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Is device.
Packaging and labelling: shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) alcohol swab in an individual sealed sterilized peel pack which provides integrity of the pack until opened.
Labelling shall have information such as name and physical address of manufacturer; b) name of the product; c) instructions for use; d) swab size e) % alcohol content; f) precaution, “for external use only” “for single use”; and “don't use when package is damaged”, g) lot/batch number; h) country of origin; i) date of manufacture; and j) expiry date i) CE mark with NB number.
Secondary packaging: Protected unit.
One (1) box of 100 individual alcohol swab.
Symbols used according ISO 15223.
Safety & product Standards:
Must comply with the following standards (must comply to the latest revision of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
BS EN 16615:2015 - Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and bactericidal activity of EN 13727 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area of equivalent .
Product description:
Swab with 70% v/v isopropyl alcohol solution.
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Minimum 4 log reduction for disinfection purpose.
Instructions for use:
Alcohol Swabs help fight bacterial and cleanse the skin. To be used when prepping the skin for an injection, as well as cleaning wounds before bandaging. Intended use, warnings, storage instructions and disposal instructions shall be provided.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Is device.
Packaging and labelling: shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) alcohol swab in an individual sealed sterilized peel pack which provides integrity of the pack until opened.
Labelling shall have information such as name and physical address of manufacturer; b) name of the product; c) instructions for use; d) swab size e) % alcohol content; f) precaution, “for external use only” “for single use”; and “don't use when package is damaged”, g) lot/batch number; h) country of origin; i) date of manufacture; and j) expiry date i) CE mark with NB number.
Secondary packaging: Protected unit.
One (1) box of 100 individual alcohol swab.
Symbols used according ISO 15223.
Safety & product Standards:
Must comply with the following standards (must comply to the latest revision of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
BS EN 16615:2015 - Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and bactericidal activity of EN 13727 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area of equivalent .
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $0.96 |
