IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Wraparound body blanket protects against cold, heat, wind and rain
Product description:
Low-weight blanket made of heat-reflective thin plastic sheeting, intended to reduce the heat loss in a person's body due to thermal radiation, water evaporation, of convection. Used to protect the body against cold, heat, wind and rain.
Thin sheet of plastic , one side coated with a metallic reflecting agent (silver of gold), reflects up to 90% of radiated heat
Lightweight flexible wrap-around blanket
Easy to unfold, strong, tear resistant
One side silver coated, reflects up to 90% of radiated heat
Wind and waterproof, and rot proof
Stays flexible in freezing temperatures
Single use, non-sterile
Materials: Non-stretch polyester film, of polyethylene terephthalate (PET),
Rectangular size, approx.: 220 x 140 cm
Dimensions:
Length, approximately: 220cm
Width, approximately: 140cm
Thickness, approximately: 12µm
Weight: approx. 0.075kg
Volume: approx. 5cdm
Instructions for use:
Wraparound body blanket protects against cold, heat, wind and rain
Arrange the silver coated surface according the desired effect:
- External - reflects heat away, isolates content against heat
- Internal - preserves (body) heat, isolates from wind and humidity
If necessary the blanket can be cut into smaller pieces for children and newborns.
Safety process:
In case of absolute necessity, the blanket may be reused after cleaning and disinfecting with chlorine solution.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) survival blanket in a plastic bag.
Labelling on the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark of similar, lot number of batch number, UDI (if MDR followed), use-by-date, symbol for Medical device
The words “Non-sterile, reusable"" (of equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable. Name and/of trademark and address of the manufacturer.
Symbols used according ISO 15223
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 Medical devices -- Quality management systems - Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
ISO 5085-1Textiles -- Determination of thermal resistance -- Part 1: Low thermal resistance
ISO 9237 Textiles -- Determination of the permeability of fabrics to air
ISO 12952-1&2&3&4 Fire resistant
ISO 13934-1 and ISO 6330 Tensile strength loss after washing
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Wraparound body blanket protects against cold, heat, wind and rain
Product description:
Low-weight blanket made of heat-reflective thin plastic sheeting, intended to reduce the heat loss in a person's body due to thermal radiation, water evaporation, of convection. Used to protect the body against cold, heat, wind and rain.
Thin sheet of plastic , one side coated with a metallic reflecting agent (silver of gold), reflects up to 90% of radiated heat
Lightweight flexible wrap-around blanket
Easy to unfold, strong, tear resistant
One side silver coated, reflects up to 90% of radiated heat
Wind and waterproof, and rot proof
Stays flexible in freezing temperatures
Single use, non-sterile
Materials: Non-stretch polyester film, of polyethylene terephthalate (PET),
Rectangular size, approx.: 220 x 140 cm
Dimensions:
Length, approximately: 220cm
Width, approximately: 140cm
Thickness, approximately: 12µm
Weight: approx. 0.075kg
Volume: approx. 5cdm
Instructions for use:
Wraparound body blanket protects against cold, heat, wind and rain
Arrange the silver coated surface according the desired effect:
- External - reflects heat away, isolates content against heat
- Internal - preserves (body) heat, isolates from wind and humidity
If necessary the blanket can be cut into smaller pieces for children and newborns.
Safety process:
In case of absolute necessity, the blanket may be reused after cleaning and disinfecting with chlorine solution.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) survival blanket in a plastic bag.
Labelling on the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark of similar, lot number of batch number, UDI (if MDR followed), use-by-date, symbol for Medical device
The words “Non-sterile, reusable"" (of equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable. Name and/of trademark and address of the manufacturer.
Symbols used according ISO 15223
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 Medical devices -- Quality management systems - Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
ISO 5085-1Textiles -- Determination of thermal resistance -- Part 1: Low thermal resistance
ISO 9237 Textiles -- Determination of the permeability of fabrics to air
ISO 12952-1&2&3&4 Fire resistant
ISO 13934-1 and ISO 6330 Tensile strength loss after washing
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.44 |
