Intended purpose of use: designed to connect to an indwelling urinary catheter to collect discharged urine from a patient.
Product description:
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.
Material for bag: polyvinyl chloride (PVC) of ethylene vinyl acetate (EVA), flexible.
Tube & connector/protective cap: polyvinyl chloride (PVC).
Urine bag has two (2) strong eyelets from which to suspend the bag.
Bag collector fitted with a non return valve. The non-return valve is located inside the urine collector bag at the upper part of urine entry point, and prevents urine backflow into the indwelling urinary catheter.
Tube with universal connector and protective cap to connect to a catheter.
Outlet tube fitted with a drain valve with seal cap allowing to maintain sterility.
Tube length: approx. 90cm.
Capacity: 2000ml.
Graduation: 100 ml.
Sterile, Single use.
Shelf life 5 yrs.
Instructions for use:
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.
Safety process:
The urine-collecting bag is for single use only.
Collect and destroy empty used bags through incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Ten (10) urine bags in a plastic bag.
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 Is device.
Safety & product Standards:
Must comply with the following standards (as per the latest revisions of standards):
ISO 8669-2:1996 Urine collection bags Requirements and test methods.
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:
ISO 14001, Alternate materials other than PVC is a preferred option.
Product description:
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.
Material for bag: polyvinyl chloride (PVC) of ethylene vinyl acetate (EVA), flexible.
Tube & connector/protective cap: polyvinyl chloride (PVC).
Urine bag has two (2) strong eyelets from which to suspend the bag.
Bag collector fitted with a non return valve. The non-return valve is located inside the urine collector bag at the upper part of urine entry point, and prevents urine backflow into the indwelling urinary catheter.
Tube with universal connector and protective cap to connect to a catheter.
Outlet tube fitted with a drain valve with seal cap allowing to maintain sterility.
Tube length: approx. 90cm.
Capacity: 2000ml.
Graduation: 100 ml.
Sterile, Single use.
Shelf life 5 yrs.
Instructions for use:
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.
Safety process:
The urine-collecting bag is for single use only.
Collect and destroy empty used bags through incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Ten (10) urine bags in a plastic bag.
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 Is device.
Safety & product Standards:
Must comply with the following standards (as per the latest revisions of standards):
ISO 8669-2:1996 Urine collection bags Requirements and test methods.
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:
ISO 14001, Alternate materials other than PVC is a preferred option.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.39 |
| Pack of 10 | $1.60 |
| Pack of 100 | $123.76 |
