Intended purpose of use: Flexible tubular device which is inserted into the bladder through the urethra to drain away urine intermittently. Not to be used as indwelling catheter.
General Description
Catheter, urethral, CH12, sterile, disposable
Technical Specifications
Urethral catheter without balloon, nelaton tip.
Atraumatic, soft, rounded closed distal end with 2 lateral eyes, proximal end with cup connector allowing catheter to be connected with urine bag. Central channel for urinary drainage
Diameter expressed in Charriere, French gauge.
Length expressed in cm.
Colour code cup connector.
Material: Polyvinyl chloride (PVC).
Size selected:
Diameter CH12, colour coded
Length: 30 - 40cm,
Single-use
Sterile. Shelf life 3 years
Initial sterilization method: Ethylene oxide gas
Packaging and labelling:
Primary packaging: Unit of use
One (1) catheter in an individual sterilised peel pack. Labelling on the primary package shall be as per regulations applied to the device. Symbols as per ISO 15223.
Secondary packaging: Protected unit.
One (1) box of 50 urethral catheters.
Instructions for use
Sterile urethral catheter without balloon, nelaton tip, designed to be introduced into the bladder cavity, to drain off urine, for short term catheterization. Use strict aseptic techniques during insertion of catheter.
If lubrication is necessary to help to introduce the catheter, the substance used must not cause physical of chemical alterations to the catheter. If necessary, use sterile water. Precautions such as "Not suitable for indwelling urinary catheterization which requires a Foley catheter with balloon". Storage conditions, disposal instructions 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 Is device
Safety & product Standards (all submissions must be as per the latest revision of standards):
Must comply with the following standards:
ISO 20696 Sterile urethral catheters for single use
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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
General Description
Catheter, urethral, CH12, sterile, disposable
Technical Specifications
Urethral catheter without balloon, nelaton tip.
Atraumatic, soft, rounded closed distal end with 2 lateral eyes, proximal end with cup connector allowing catheter to be connected with urine bag. Central channel for urinary drainage
Diameter expressed in Charriere, French gauge.
Length expressed in cm.
Colour code cup connector.
Material: Polyvinyl chloride (PVC).
Size selected:
Diameter CH12, colour coded
Length: 30 - 40cm,
Single-use
Sterile. Shelf life 3 years
Initial sterilization method: Ethylene oxide gas
Packaging and labelling:
Primary packaging: Unit of use
One (1) catheter in an individual sterilised peel pack. Labelling on the primary package shall be as per regulations applied to the device. Symbols as per ISO 15223.
Secondary packaging: Protected unit.
One (1) box of 50 urethral catheters.
Instructions for use
Sterile urethral catheter without balloon, nelaton tip, designed to be introduced into the bladder cavity, to drain off urine, for short term catheterization. Use strict aseptic techniques during insertion of catheter.
If lubrication is necessary to help to introduce the catheter, the substance used must not cause physical of chemical alterations to the catheter. If necessary, use sterile water. Precautions such as "Not suitable for indwelling urinary catheterization which requires a Foley catheter with balloon". Storage conditions, disposal instructions 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 Is device
Safety & product Standards (all submissions must be as per the latest revision of standards):
Must comply with the following standards:
ISO 20696 Sterile urethral catheters for single use
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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 50 | $7.50 |
