IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Used under the patient to cover the operating table to protect against soaking.
Used to cover beds of patients with extensive wounds to protect against soaking.
Product description:
Rectangular plastic sheet, used to protect equipment from soiling.
Material: Non-woven fabric.
1st layer polyethylene, shiny side.
2nd layer non-woven absorbent material, viscose type.
The non-woven fabric must be reinforced lengthwise with blue polyether fibres.
- Absorbent and impervious protection.
- Good resistance to tears.
- Individually folded for swift fitting.
- Non-allergic.
- Hygienically clean for hospital use.
Size: approx. 80 x 120cm.
Instructions for use:
The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
After the first use it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: 1 single-use draw sheet, folded.
Secondary packaging: 75 units per carton.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223
CE Mark
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:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Used under the patient to cover the operating table to protect against soaking.
Used to cover beds of patients with extensive wounds to protect against soaking.
Product description:
Rectangular plastic sheet, used to protect equipment from soiling.
Material: Non-woven fabric.
1st layer polyethylene, shiny side.
2nd layer non-woven absorbent material, viscose type.
The non-woven fabric must be reinforced lengthwise with blue polyether fibres.
- Absorbent and impervious protection.
- Good resistance to tears.
- Individually folded for swift fitting.
- Non-allergic.
- Hygienically clean for hospital use.
Size: approx. 80 x 120cm.
Instructions for use:
The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
After the first use it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: 1 single-use draw sheet, folded.
Secondary packaging: 75 units per carton.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223
CE Mark
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:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.78 |
