Product description:
Hemmed rectangular textile used for making up a hospital bed.
Fabric: cretonne, cotton 100%:
- Number of threads/cm: warp: 24, weft: 24
- Metric count: warp: 28, weft: 28
- Weight per m²: 180g
Size: 289 x 178 cm for a mattress hospital bed of 200 x 85 x 12 cm.(l x w x h)
4 hemmed borders.
Colour: white.
Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine.
Packaging and labelling:
Unit presentation: 1 sheet, non-sterile, multiple-use, size and Manufacturer's name.
Packaging: Protected in a plastic bag, single of multiple units.
Labelling of 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.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable.
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:
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $14.46 |
