Product description:
Sterile mucus extractor device used for aspirating secretions of other liquids obstructing the pharynx of airways pharynx in newborn babies to ensure free respiration.
Components: Transparent container to permit immediate visual examination of the mucus.
Catheter, size selected: CH12, with open end smooth round tip for trauma free insertion, distal end with conical tip. Catheter tip ensures atraumatic intubation.
2 catheters, one from the reservoir to operator’s mouth and the second one for suction.
With filter to prevent entry of mucus to users mouth during suction.
Single chamber container, plastic
Self-adhesive identification label for newborn identification
Material:
Container: polypropylene, medical grade
Catheters: polyvinyl chloride, medical grade
Capacity: approx. 20 ml.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas of Gamma radiation.
Instructions for use:
Sterile mucus extractor device used for aspirating secretions 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.
Safety process:
The mucus extractor is for single use only.
When inserting a suction tube, use clean techniques.
Collect and destroy by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use. Indications for use, warnings, contraindications if any. Storage conditions and disposal instructions to be included.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use
One (1) mucus extractor in an individual sterilised peel pack.
Secondary packaging: Protected unit.
One (1) box of 50 mucus extractors.
Symbols used according ISO 15223
CE mark with 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 Is device
Safety & product Standards (must be as per latest revisions of the standards):
Must comply with the following standards:
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 10993-1 Biological Evaluation of medical devices
Environmental requirements:
ISO 14001
Sterile mucus extractor device used for aspirating secretions of other liquids obstructing the pharynx of airways pharynx in newborn babies to ensure free respiration.
Components: Transparent container to permit immediate visual examination of the mucus.
Catheter, size selected: CH12, with open end smooth round tip for trauma free insertion, distal end with conical tip. Catheter tip ensures atraumatic intubation.
2 catheters, one from the reservoir to operator’s mouth and the second one for suction.
With filter to prevent entry of mucus to users mouth during suction.
Single chamber container, plastic
Self-adhesive identification label for newborn identification
Material:
Container: polypropylene, medical grade
Catheters: polyvinyl chloride, medical grade
Capacity: approx. 20 ml.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas of Gamma radiation.
Instructions for use:
Sterile mucus extractor device used for aspirating secretions 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.
Safety process:
The mucus extractor is for single use only.
When inserting a suction tube, use clean techniques.
Collect and destroy by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use. Indications for use, warnings, contraindications if any. Storage conditions and disposal instructions to be included.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use
One (1) mucus extractor in an individual sterilised peel pack.
Secondary packaging: Protected unit.
One (1) box of 50 mucus extractors.
Symbols used according ISO 15223
CE mark with 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 Is device
Safety & product Standards (must be as per latest revisions of the standards):
Must comply with the following standards:
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 10993-1 Biological Evaluation of medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.31 |
| Pack of 50 | $18.34 |
| Pack of 10 | $23.05 |
| Pack of 100 | $230.50 |
