Product description:
Bladder syringe 60-100 mls for washing out the stomach of the administration of liquid foods and for bladder irrigation
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an individual blister pack. Pre-sterilized.
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
Instruction for use:
Instrument for irrigation of the urinary bladder.
Supplied with:
Manufacturer's instruction for use.
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 & product Standards:
Must comply with the following standards:
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 20594-1:1994, ISO 594-1:1986
EN ISO 7886-1:1997
Product and packaging complies with WHO PQS E08.
Environmental requirements:
Polymer not PVC
Bladder syringe 60-100 mls for washing out the stomach of the administration of liquid foods and for bladder irrigation
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an individual blister pack. Pre-sterilized.
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
Instruction for use:
Instrument for irrigation of the urinary bladder.
Supplied with:
Manufacturer's instruction for use.
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 & product Standards:
Must comply with the following standards:
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 20594-1:1994, ISO 594-1:1986
EN ISO 7886-1:1997
Product and packaging complies with WHO PQS E08.
Environmental requirements:
Polymer not PVC
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $52.00 |
