Intended purpose of use: Accessories for MVA.
Product description: A package of items to be used as spare parts and lubricant for MVA.
The kit includes:
- Plunger O-ring , spare part to replace damaged O-ring.
- Collar stop, spare part to replace damaged collar stop.
- Cap, spare part to replace damaged cap.
- Silicone tube ( 2 cc), used to lubricate the O-ring.
Material:
O-ring: synthetic rubber latex free.
Collar stop and cap: Latex-free plastic.
Lubricant: medical grade silicone.
Non sterile.
Instructions for use:
Caution: Excessive lubrication can cause the aspirator to lose vacuum.
Do not over lubricate the plunger O-ring.
Do not lubricate other parts of the aspirator.
To be sterilized prior to initial use and between patients. Autoclavable at 121ºC.
Supplied with:
- 1x Plunger O-ring.
- 1x collar Stop.
- 1x cap.
- 1x silicone tube ( 2 cc).
- 1x Instruction for use.
Packaging and labelling:
One (1) MVA accessory kit in a plastic bag with manufacturer's instruction for user in English.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer.
Information for particular storage conditions(temperature, pressure,
light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223 and EN 980.
CE mark, Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device.
Safety & product Standards:
Must comply with the following standards:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes.
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
Environmental requirements: ISO 14001.
Product description: A package of items to be used as spare parts and lubricant for MVA.
The kit includes:
- Plunger O-ring , spare part to replace damaged O-ring.
- Collar stop, spare part to replace damaged collar stop.
- Cap, spare part to replace damaged cap.
- Silicone tube ( 2 cc), used to lubricate the O-ring.
Material:
O-ring: synthetic rubber latex free.
Collar stop and cap: Latex-free plastic.
Lubricant: medical grade silicone.
Non sterile.
Instructions for use:
Caution: Excessive lubrication can cause the aspirator to lose vacuum.
Do not over lubricate the plunger O-ring.
Do not lubricate other parts of the aspirator.
To be sterilized prior to initial use and between patients. Autoclavable at 121ºC.
Supplied with:
- 1x Plunger O-ring.
- 1x collar Stop.
- 1x cap.
- 1x silicone tube ( 2 cc).
- 1x Instruction for use.
Packaging and labelling:
One (1) MVA accessory kit in a plastic bag with manufacturer's instruction for user in English.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer.
Information for particular storage conditions(temperature, pressure,
light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223 and EN 980.
CE mark, Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device.
Safety & product Standards:
Must comply with the following standards:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes.
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.16 |
