Intended purpose of use: non-invasive sterile device to conduct fluids (except blood and blood products) from an intravenous fluid container to a patient's venous system.
Product description:
A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system; used for gravitational intravenous administration.
Components:
Tubing.
Spike of perforator.
Air inlet with air filter and protective cap.
Drip-counting chamber.
Flow regulator.
Y-injection site.
Luer-lock connection to vascular system.
Materials: The material of construction shall be medical grade and must not modify the properties of the fluids of solutions passing through the infusion set.
Tube: plastic (PVC: polyvinyl chloride), medical grade. DEHP free. Transparent (allowing the detection of air bubbles). Resistant to kinking.
Length is approximately 150cm (overall IV giving set length approximately 170cm). Internal / external diameter is 3 mm / 4.1mm.
Plastic Perforator: Medical grade plastic ABS (Acrylonitrile Butadiene Styrene), POM (polyacetal), polystirole.
Double Channel, Hollow device located at the proximal end of the infusion set allowing it to be connected to the infusion bottle of bag. Composed of a tapering tube mounted on a base ensuring a good seal between the set and the infusion bottle of bag.
Fitted with a protecting cap and air inlet.
Air inlet: plastic (ABS: acrylonitrile butadiene styrene).
Incorporated into the perforator. Fitted with an air filter (bacteriological filter).
Drop-counting chamber:
Materials: medical-grade PVC and polypropylene. Transparent, supple, compressible bag with calibrated tube (upper end) providing even drop formation: 20 drops of ±1ml.
- Bacterial filter 15-20µm (chamber, lower end) designed to retain particles.
Flow regulator: plastic (ABS: acrylonitrile butadiene styrene).
Ensures the flow regularity during the IV administration. (Clamp to control administration speed/volume).
Injection portal: plastic (ABS: acrylonitrile butadiene styrene)+ synthetic rubber.
Allows introducing precise volume of injectable medicines into the infusion flow. Natural rubber latex-free
Y-shaped, self-sealing membrane made of synthetic elastomer.
Terminal connection (stopper): plastic (ABS: acrylonitrile butadiene styrene).
With Luer lock connector.
Includes expiration date (shelf life).
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Instructions for use:
Sterile item, used for parenteral administration of injectable preparations.
Sterile infusion giving set with graduated chamber enabling a slow intravenous administration of a precise volume of infusion of injectable drug over a given time. It is to be connected between the infusion and the intravenous catheter.
An infusion giving set should not be left in situ for more than 72 hours.
Not for use with blood of blood products of light sensitive products.
Supplied with:
Manufacturer's instruction for use. Storage conditions, disposal instructions, precautions for use, warnings etc.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) Infusion giving set in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 10 Infusion giving set units.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Product description:
A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system; used for gravitational intravenous administration.
Components:
Tubing.
Spike of perforator.
Air inlet with air filter and protective cap.
Drip-counting chamber.
Flow regulator.
Y-injection site.
Luer-lock connection to vascular system.
Materials: The material of construction shall be medical grade and must not modify the properties of the fluids of solutions passing through the infusion set.
Tube: plastic (PVC: polyvinyl chloride), medical grade. DEHP free. Transparent (allowing the detection of air bubbles). Resistant to kinking.
Length is approximately 150cm (overall IV giving set length approximately 170cm). Internal / external diameter is 3 mm / 4.1mm.
Plastic Perforator: Medical grade plastic ABS (Acrylonitrile Butadiene Styrene), POM (polyacetal), polystirole.
Double Channel, Hollow device located at the proximal end of the infusion set allowing it to be connected to the infusion bottle of bag. Composed of a tapering tube mounted on a base ensuring a good seal between the set and the infusion bottle of bag.
Fitted with a protecting cap and air inlet.
Air inlet: plastic (ABS: acrylonitrile butadiene styrene).
Incorporated into the perforator. Fitted with an air filter (bacteriological filter).
Drop-counting chamber:
Materials: medical-grade PVC and polypropylene. Transparent, supple, compressible bag with calibrated tube (upper end) providing even drop formation: 20 drops of ±1ml.
- Bacterial filter 15-20µm (chamber, lower end) designed to retain particles.
Flow regulator: plastic (ABS: acrylonitrile butadiene styrene).
Ensures the flow regularity during the IV administration. (Clamp to control administration speed/volume).
Injection portal: plastic (ABS: acrylonitrile butadiene styrene)+ synthetic rubber.
Allows introducing precise volume of injectable medicines into the infusion flow. Natural rubber latex-free
Y-shaped, self-sealing membrane made of synthetic elastomer.
Terminal connection (stopper): plastic (ABS: acrylonitrile butadiene styrene).
With Luer lock connector.
Includes expiration date (shelf life).
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Instructions for use:
Sterile item, used for parenteral administration of injectable preparations.
Sterile infusion giving set with graduated chamber enabling a slow intravenous administration of a precise volume of infusion of injectable drug over a given time. It is to be connected between the infusion and the intravenous catheter.
An infusion giving set should not be left in situ for more than 72 hours.
Not for use with blood of blood products of light sensitive products.
Supplied with:
Manufacturer's instruction for use. Storage conditions, disposal instructions, precautions for use, warnings etc.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) Infusion giving set in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 10 Infusion giving set units.
Symbols used according ISO 15223.
CE mark with Notified Body number.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.21 |
| Pack of 100 | $12.09 |
| Pack of 500 | $70.40 |
| Pack of 400 | $84.18 |
