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INFUSION SET WITH Y-INJECTION SET CONNECTOR RAYS

Infusion set RAYS with flow regulator, with filter, air inlet tube 1,5m, drip chamber with 15 micron, luer lock RAYS Italy.
Manufacturer: Rays
SKU: 257-04-008

Infusion set RAYS with Y-set injection

Infusion set RAYS with flow regulator, with filter, air inlet tube 1,5m, drip chamber with 15 micron, luer lock RAYS Italy.

Commercial name: INFUSION SET
Purpose of use: latex-free infusion set with flow regulator without the following Phthalates (DBP, BBP, DEHP, DNOP, DIDP) for administration of solutions with luer lock connector (surgical invasive short-term device)

CND: Medical Devices National Classification– D.M. 20/02/2007: A03010103
Description: infusion set composed of:
ABS spike with Z-Type air vent and filter from 0,45 micron
PVC chamber without the following Phthalates (DBP, BBP, DEHP, DNOP, DIDP) with 15 micron filter
PVC tube length 150cm without the following Phthalates (DBP, BBP, DEHP, DNOP, DIDP)
Safety ABS roller
Flow regulator in white ABS and silicon, with printed blue double graduated scale from 5 to 250ml/h
Latex-free Y injection point
Transparent ABS luer lock terminal
Cap for spike
Cap for luer lock terminal

Packaging: single packaging in blister – bags in polyethylene with 20 pcs – 18 bags with 20 pcs (360 pcs) in each carton
Labelling: BLISTER – primary selling package – single – steril
- Product description
- Commercial name
- Product code
- Sterilization method
- Sterile (symbol)
- Disposable (symbol)
- Latex free (symbol)
- Phthalate free (symbol)
- EC certification (symbol)
- Name and address of manufacturer
- Name and address of mandatary
- Batch, production and expiry date
- Specific instructions for use
- Barcode EAN 13: 8034055916193
- Storage
- Opening invitation
CARTON – containing 18 big bags with 20 infusion sets – total 360 pieces
- Product description
- Commercial name
- Product code
- Sterilization method
- Sterile (symbol)
- Disposable (symbol)
- Latex free (symbol)
- Phthalate free (symbol)
- EC certification (symbol)
- Name and address of manufacturer
- Name and address of mandatary
- Batch, production and expiry date
- Quantity
- Barcode EAN 13: 8034055916193
- Storage
Product traceability: Each product has a batch number which allows its traceability and, if necessary, its block and/or its recall as provided by the EEC Directive 93/42 put into effect with the Legislative Decree 46/97 and subsequent modifications and integrations
Sterilization method: Sterilized by Ethylene Oxide (EtO)
Residual gas according to the applicable regulations.
Sterilization Validity 5 years

Air vent: The device for the air intake has a filter per air which prevents the entry of the micro-organisms within the container where the infusion tube was inserted. When the infusion tube is inserted into a rigid container for infusion, the air filled inside the container will not go in to the spurted liquid. The Air vent is placed in a way that all the air entering in to the rigid container passes through itself. The flow of the liquid is not reduced more than 20% of that freely ventilated container. The air vent is available also Z-Type.
Tube: The tube is made with Medical grade PVC (available also in PVC free by the following phthalates: DBP, BBP, DEHP, DINP, DNOP, DIDP), sufficiently transparent and clear enough in order to observe the flow of the physiological solutions and the air bubbles. The length of the tube is 150 or 200 cm.
Dripper: The dripper in the chamber permits a continuous observation for the drop falls. The liquid enters in the chamber through a tube that reaches to the chamber. There is a distance not less than 40 mm between the end of the dripper tube and the base of the chamber. The dripper tube is such that 20 or 60 drops of distilled water( 23°C+2°C) with the flow of 50 drops min. + 10 drops min. generate a volume of 1 ml +0.1 ml (1 g +0.1 g).
Flow Regulator: The Flow regulator regulates the flow of the solution between zero and the maximum. The Flow regulator could be used continuously during an infusion and without damaging the tube.
The injection site: The injection site is available in Y or hose type. After perforating a hypodermic needle with an outer diameter of 0.6 mm to the self sealant injection and having held the needle in position for 15s, it closes and the maximum loss is a drop of water.
Protective caps: The protective caps maintain sterility of the spike, the luer or luer-lock connector (or the needle, if present) and the interior of the infusion set.
Latex -free: Infusion set and the relevant packaging are completely latex-free.
Phthalates: The presence of phthalates deemed to be dangerous for reproduction, makes this device considered not suitable for use on children and on pregnant and in-feeding women.
Compatibility to pharmaceuticals: This product is not intended to interact with the substances that they contact with, therefore the incompatibility episodes with disinfectants, infusion solutions , biological materials etc. are not known. They are not explicitly considered incompatible with the constituent materials of the product for incompatible pharmaceuticals with PVC and for the light-sensitive solutions exist specific products.
Conservation: Store in a cool dry place and far away from the any source of heat at a temperature between 5° C and 40°C
Disposal: Disposal must be made in accordance with the applicable government regulations. Incineration or landfill disposal must be carried out under controlled conditions. The product that didn’t come in to contact with infectious agents or other hazardous materials do not produce toxic residue.