Intended purpose of use: for bladder irrigation.
Product description:
Bladder syringe 100 ml.
Materials: Made of polypropylene (PP).
3-piece syringe:
Barrel: Transparent with contrast graduation: permanent markings and good legibility.
Plunger stopper with backstop.
Double sealing ring on plunger.
Graduation in ml for the volume dosage.
With centric-catheter fitting cone for a tube with a funnel connection (e.g., gastric tube).
With long nozzle.
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Shelf life 5 years.
Supplied with:
Manufacturer's instruction for use irrigation of the urinary bladder, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Packaging: 1 syringe, sterile, peel pack, single-use.
Secondary packaging: Protected unit.
One (1) box of 25 syringes.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
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 and Product Standards (shall comply to the current versions of the following standards):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
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 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for oscular of hypodermic applications.
ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 10993: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
Product description:
Bladder syringe 100 ml.
Materials: Made of polypropylene (PP).
3-piece syringe:
Barrel: Transparent with contrast graduation: permanent markings and good legibility.
Plunger stopper with backstop.
Double sealing ring on plunger.
Graduation in ml for the volume dosage.
With centric-catheter fitting cone for a tube with a funnel connection (e.g., gastric tube).
With long nozzle.
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Shelf life 5 years.
Supplied with:
Manufacturer's instruction for use irrigation of the urinary bladder, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling:
Packaging: 1 syringe, sterile, peel pack, single-use.
Secondary packaging: Protected unit.
One (1) box of 25 syringes.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
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 and Product Standards (shall comply to the current versions of the following standards):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
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 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for oscular of hypodermic applications.
ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 10993: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.90 |
