Product description:
Urine collection bag.
Medical grade plastic bag, capacity 2000ml, with graduated scale every 100 ml to allow proper reading of the liquid contained in the bag and reinforced eyelets for hanging.
Kink-resistant and transparent plastic inlet tube, length +/- 90cm, with universal connector and protective cap.
With outlet which permits bag to be emptied without disconnecting.
Material:
Bag: polyvinyl chloride (PVC) of ethylene vinyl acetate (EVA).
Tubing & connector/protective cap: polyvinyl chloride (PVC)
Single-use
Non sterile
Instructions for use:
The 2-litre urine collecting bag is used for collecting urine from a patient via a urinary (e.g. Foley) catheter, which makes the bag part of a closed system. The size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Five (5) of Ten (10) urine bags in a plastic bag
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
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.
Expiry date by year and month, prefixed by the word "EXP"(of equivalent harmonised symbol) if applicable.
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 IIa device
Safety & product Standards:
Must comply with the following standards:
EN 1616:1997: Sterile urethral catheters for single use
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
Environmental requirements:
Latex free, it is recommended to use silicone
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.17 |
| Pack of 25 | $8.00 |
