Intended purpose of use: For prolonged peripheral intravenous infusions.
Product description:
Sterile Intravenous (IV) Cannula to be introduced into a peripheral vein for infusing fluids, administering IV drugs, transfusing blood and blood products (for infant and children use).
Components: Protecting cap, trocar, Cannula, stopper, injection port, Luer lock (proximal part) (all parts fit together to form a unit).
Material for trocar: Stainless steel
Material for Cannula: PTFE (Poly Tetra Fluoro Ethylene), FEP (Fluorinated Ethylene Propylene), PUR (Polyurethane).
DEHP free, should be non thrombogenic, Non Toxic and Non Pyrogenic.
Size: 22G (0.90 x 25mm) blue.
Flow rate approx. 33ml/min
Colour code/external diameter: Visible at the base of Cannula.
Cannula with fine and tapered walls, perfectly adjusted to the needle.
Distal end: straight and tapering.
Proximal end base fitted with luer lock connector, 2 gripping wings (butterfly), standardized colour code depending on the diameter.
Fitted with a lateral injection port.
Injection port fitted with silicone anti-reflux valve, cap with colour code and chimney of luer type.
Protecting cap.
Stopper fitted with a hydrophobic membrane with micro-perforations to let the air flow while stopping blood, male luer connection.
Triple-bevelled trocar (ensures a good skin penetration and reduces vein trauma.)
Transparent female luer base.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas.
Instructions for use:
Sterile IV Cannula to be introduced into a peripheral vein for infusing fluids, administering IV drugs, transfusing blood and blood products.
Safety process:
IV Cannula is for single use only.
Rules of asepsis must be followed when inserting IV Cannula.
IV Cannula should not be left in situ for more than 72 hours. It should be removed immediately in case of infection sign.
Supplied with: Manufacturer's instruction for use.
Shall contain instructions for storage, use, safe disposal, and warning to users. Warning shall include statements such as " protection of users: To prevent stick injuries, wear gloves. NEVER recap the trocar after use and dispose of the needle into a puncture proof safety container". Must be multilingual: English, French and Spanish
Packaging and labelling:
Primary packaging: One (1) IV Cannula in an individual sterilised peel pack, preferably transparent to see the colour, else colour shall be printed on the primary package.
Secondary packaging: Protected unit.
One (1) box of 50 IV cannulas.
Labelling on primary packaging: Shall be as per regulatory requirements applied to the device. Manufacture’s name and/of trademark, product description and reference number, "sterile" with method indicated, lot number, expiry date by year and month, "for single use", and CE mark and reference number for notifying body.
Symbols used according ISO 15223
CE Mark and Notified Body number
Product description:
Sterile Intravenous (IV) Cannula to be introduced into a peripheral vein for infusing fluids, administering IV drugs, transfusing blood and blood products (for infant and children use).
Components: Protecting cap, trocar, Cannula, stopper, injection port, Luer lock (proximal part) (all parts fit together to form a unit).
Material for trocar: Stainless steel
Material for Cannula: PTFE (Poly Tetra Fluoro Ethylene), FEP (Fluorinated Ethylene Propylene), PUR (Polyurethane).
DEHP free, should be non thrombogenic, Non Toxic and Non Pyrogenic.
Size: 22G (0.90 x 25mm) blue.
Flow rate approx. 33ml/min
Colour code/external diameter: Visible at the base of Cannula.
Cannula with fine and tapered walls, perfectly adjusted to the needle.
Distal end: straight and tapering.
Proximal end base fitted with luer lock connector, 2 gripping wings (butterfly), standardized colour code depending on the diameter.
Fitted with a lateral injection port.
Injection port fitted with silicone anti-reflux valve, cap with colour code and chimney of luer type.
Protecting cap.
Stopper fitted with a hydrophobic membrane with micro-perforations to let the air flow while stopping blood, male luer connection.
Triple-bevelled trocar (ensures a good skin penetration and reduces vein trauma.)
Transparent female luer base.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas.
Instructions for use:
Sterile IV Cannula to be introduced into a peripheral vein for infusing fluids, administering IV drugs, transfusing blood and blood products.
Safety process:
IV Cannula is for single use only.
Rules of asepsis must be followed when inserting IV Cannula.
IV Cannula should not be left in situ for more than 72 hours. It should be removed immediately in case of infection sign.
Supplied with: Manufacturer's instruction for use.
Shall contain instructions for storage, use, safe disposal, and warning to users. Warning shall include statements such as " protection of users: To prevent stick injuries, wear gloves. NEVER recap the trocar after use and dispose of the needle into a puncture proof safety container". Must be multilingual: English, French and Spanish
Packaging and labelling:
Primary packaging: One (1) IV Cannula in an individual sterilised peel pack, preferably transparent to see the colour, else colour shall be printed on the primary package.
Secondary packaging: Protected unit.
One (1) box of 50 IV cannulas.
Labelling on primary packaging: Shall be as per regulatory requirements applied to the device. Manufacture’s name and/of trademark, product description and reference number, "sterile" with method indicated, lot number, expiry date by year and month, "for single use", and CE mark and reference number for notifying body.
Symbols used according ISO 15223
CE Mark and Notified Body number
| Pack Size | Avg. Price |
|---|---|
| Pack of 50 | $6.11 |
