Intended purpose of use: to collect waste from the stoma.
Product description:
The colostomy pouch is one piece open system, with deodorising filter and pre-cut opening.
It is a medical device that consists of a bag attached to the patient's skin by an adhesive material.
The pouch is drainable from the bottom and kept closed by a removable safety clamp.
Bag: Made of flexible transparent plastic with a non woven protection layer on skin side.
Shape: Anatomical shaped with smooth edges.
Adhesive attachment system: 12 x 12 cm, with hydrocolloid skin protector, to ensure, safe continuity between bag and colostomy.
Cut-to-fit ostomy bags allow the pouch to fit the shape and size of most stomas
Hygienically packed for medical use. Non sterile, Single use only.
Measurements:
Size: Bag: Length 19 x width 14cm with:
Window/aperture: starts at Ø +/- 14mm then pre-cut marking up to 64mm.
Pre-cut marking: 25/38/51 and 64mm.
Filter: for absorbing gases and unpleasant smell produced by bowels.
Clip: with secure closing system.
Material:
Bag: Polyvinyl chloride (PVC), Low density polyethylene (LDPE), Ethylene vinyl acetate (EVA).
Filter: Charcoal granulates.
Clip: ll Plastic
Shelf life 3 years.
Packing and labelling: Shall be as per regulatory compliance applied to the device.
ll closing clip by 20 pieces.
Each carton to be clearly identified with product name & characteristics, manufacturer addressee, lot No, number of units per carton and multilingual user manual.
Instructions for use: Supplied with IFU in multilingual. Instructions for use such as cutting the adhesive disc, preparation of skin, application on the skin and removal after use. Shall include storage and disposal instructions. Shall include any warnings, precautions for use etc.
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 (all submissions must be as per the latest revision of standards):
Must comply with the following standards:
ISO 8670-2: Ostomy collection bags -- Part 2: Requirements and test methods
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Environmental requirements:
ISO 14001
Product description:
The colostomy pouch is one piece open system, with deodorising filter and pre-cut opening.
It is a medical device that consists of a bag attached to the patient's skin by an adhesive material.
The pouch is drainable from the bottom and kept closed by a removable safety clamp.
Bag: Made of flexible transparent plastic with a non woven protection layer on skin side.
Shape: Anatomical shaped with smooth edges.
Adhesive attachment system: 12 x 12 cm, with hydrocolloid skin protector, to ensure, safe continuity between bag and colostomy.
Cut-to-fit ostomy bags allow the pouch to fit the shape and size of most stomas
Hygienically packed for medical use. Non sterile, Single use only.
Measurements:
Size: Bag: Length 19 x width 14cm with:
Window/aperture: starts at Ø +/- 14mm then pre-cut marking up to 64mm.
Pre-cut marking: 25/38/51 and 64mm.
Filter: for absorbing gases and unpleasant smell produced by bowels.
Clip: with secure closing system.
Material:
Bag: Polyvinyl chloride (PVC), Low density polyethylene (LDPE), Ethylene vinyl acetate (EVA).
Filter: Charcoal granulates.
Clip: ll Plastic
Shelf life 3 years.
Packing and labelling: Shall be as per regulatory compliance applied to the device.
ll closing clip by 20 pieces.
Each carton to be clearly identified with product name & characteristics, manufacturer addressee, lot No, number of units per carton and multilingual user manual.
Instructions for use: Supplied with IFU in multilingual. Instructions for use such as cutting the adhesive disc, preparation of skin, application on the skin and removal after use. Shall include storage and disposal instructions. Shall include any warnings, precautions for use etc.
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 (all submissions must be as per the latest revision of standards):
Must comply with the following standards:
ISO 8670-2: Ostomy collection bags -- Part 2: Requirements and test methods
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 10 | $12.96 |
| Pack of 20 | $26.72 |
