Intended purpose of use: for periodic aspiration of liquids and/of semi-solids from a patient's upper airway.
Product description:
Sterile suction catheter for single use.
Material: Polyvinyl chloride (PVC) DEHP free.
Diameter size :Diameter expressed in Charriere, French gauge. Gauge CH10.
Length expressed in cm. Length approx. 50cm.
Tube: Straight distal end with 2 side windows.
Cup connector: Conical tip.
Colour code/ external diameter: Visible on cup connector.
The suction tube consists of a single channel tube with open distal end with side windows.
Proximal end with cup connector (conical tip) allowing the tube to be connected to devices such as suction pump system.
Disposable, single use.
Sterile.
Initial sterilisation method: Ethylene oxide gas.
Shelf life to be included.
Instructions for use:
Sterile suction tube device used for aspirating pus, blood, secretions, food of other liquids obstructing the pharynx of airways.
The sterile suction tube device is introduced either via the mouth, nose, through the channel of endotracheal tube of tracheostomy tube.
The size has been chosen as being the most commonly used.
Conditions for stock:
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use.
Single use material, supplied in sterile packaging. Do not use if the packaging is damaged.
Safety process:
The suction tube is for single use only.
When inserting a suction tube: use clean techniques.
Collect and destroy by incineration in a controlled.
Supplied with:
Manufacturer's instruction for use, indications for use (such as "This tube can be connected: either to a syringe with conical tip for manual aspiration of to a mechanical of electrical suction system"), contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Primary packaging:
-One (1) suction tube packed in an individual sterilised peel-pack made of paper and/of plastic.
Labelling on the primary packaging:
- Name and/of trade mark, and address of f the manufacturer.
- Manufacturer's product reference.
- Type of product and main characteristics.
- The word "sterile" (of equivalent harmonised symbol).
- Sterilisation method (of equivalent harmonised symbol).
- Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
- Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol).
- The words "of single use" (of equivalent harmonised symbol).
- The words "check the integrity of the individual sterilised pack before use" (of equivalent harmonised symbol).
Symbols used according ISO 15223 and EN 980.
CE mark and Notified Body number.
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 IIa device.
Environmental requirements: ISO 14001.
Product description:
Sterile suction catheter for single use.
Material: Polyvinyl chloride (PVC) DEHP free.
Diameter size :Diameter expressed in Charriere, French gauge. Gauge CH10.
Length expressed in cm. Length approx. 50cm.
Tube: Straight distal end with 2 side windows.
Cup connector: Conical tip.
Colour code/ external diameter: Visible on cup connector.
The suction tube consists of a single channel tube with open distal end with side windows.
Proximal end with cup connector (conical tip) allowing the tube to be connected to devices such as suction pump system.
Disposable, single use.
Sterile.
Initial sterilisation method: Ethylene oxide gas.
Shelf life to be included.
Instructions for use:
Sterile suction tube device used for aspirating pus, blood, secretions, food of other liquids obstructing the pharynx of airways.
The sterile suction tube device is introduced either via the mouth, nose, through the channel of endotracheal tube of tracheostomy tube.
The size has been chosen as being the most commonly used.
Conditions for stock:
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use.
Single use material, supplied in sterile packaging. Do not use if the packaging is damaged.
Safety process:
The suction tube is for single use only.
When inserting a suction tube: use clean techniques.
Collect and destroy by incineration in a controlled.
Supplied with:
Manufacturer's instruction for use, indications for use (such as "This tube can be connected: either to a syringe with conical tip for manual aspiration of to a mechanical of electrical suction system"), contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Primary packaging:
-One (1) suction tube packed in an individual sterilised peel-pack made of paper and/of plastic.
Labelling on the primary packaging:
- Name and/of trade mark, and address of f the manufacturer.
- Manufacturer's product reference.
- Type of product and main characteristics.
- The word "sterile" (of equivalent harmonised symbol).
- Sterilisation method (of equivalent harmonised symbol).
- Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
- Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol).
- The words "of single use" (of equivalent harmonised symbol).
- The words "check the integrity of the individual sterilised pack before use" (of equivalent harmonised symbol).
Symbols used according ISO 15223 and EN 980.
CE mark and Notified Body number.
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 IIa device.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.13 |
