Skip to main content

Bowl, polypropylene, 6L - 1000292

Product ID: ITM-1000292
generic
IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.

Intended purpose of use: A round shaped container that is for general ward use/nursing area.

Product Description:
Receptacle for liquids and other materials, for general use.
Round container made of polypropylene, smooth, non-glare surface.
Material: Polypropylene, autoclavable.
Inner diameter: approximately 345mm.
Height: approximately 120mm.
Capacity: approximately 6000 ml
shall provide the weight of the item (5% tolerance limit allowed)

Packaging and labelling:
Over packaging: Packaging unit
Labelling on the primary packaging:
Name and address of the manufacturer. Provide brand name/trade mark details if any.
Manufacturer's product reference.
Type of product and main characteristics.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol), if applicable.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Symbols used according ISO 15223
CE Mark

Instructions for use:
For general ward use
to be provided in English/French/Arabic/Spanish.
cleaning, disinfecting and sterilization instructions, list of non computable disinfectants, if any

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 ( as per latest revisions of product standards):
Must comply with following standards
ISO 7153-1:1991 Surgical instruments --Metallic materials --Part 1: Stainless steel

Pack SizeAvg. Price
Pack of 1$2.80