Product Description: Components of one unit: needle with protective cap, butterfly wings, tube including a Luer connector with a cap (all parts fit together to form one unit).
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Needle:
Material: stainless steel.
Sharp and silicone-coated for atraumatic insertion.
Mounted on a polymer base with two flexible fins that are used for anchoring and attaching the needle.
Thin needle walls.
Size selected: 25G (0.5x19 mm).
With a protective cap.
Butterfly wings:
For better fixations and handling.
Color code as per ISO 6009: orange
Material: medical grade plastic or PVC.
The external diameter (mm and gauge): Visible on the wings.
Tube:
Material: DEHP free polyurethane (PUR).
Soft, flexible.
Length: approx. 150-300 mm.
ending in a female Luer connector fitted with a stopper allowing an infusion set to be connected.
Connector:
Female Luer.
Usually interlocking that permits the attachment of an infusion set.
Intended use:
Sterile scalp vein needle to be introduced into a peripheral vein for infusing fluids and administering IV drugs.
Scalp vein needle are for short duration use, for longer duration use, it is preferable to use IV Cannula, which causes less irritation to the veins.
The needle should be held in the correct position by suitable dressing, allowing the observation of the site of insertion, and providing efficient barrier against infection.
The selected sizes are the most commonly used:
- 21G (0.80 x 19 mm) green, for adults.
- 25G (0.50 x 19 mm) orange, for children.
Safety process: The needle is for single use only. When inserting a needle: use aseptic techniques.
Supplied with:
Manufacturer’s instructions for use may be printed onto the primary packaging or provided on a separate insert.
Languages: English, Spanish and French.
Packaging and Labelling:
Primary packaging:
One (1) scalp vein needle unit packed in individual sterilised peel-pack.
Secondary packaging:
One (1) carton box of fifty (50) scalp vein needle units to blister packs.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words "for single use" (or equivalent harmonised symbol).
The words "check the package integrity before use", or similar warning.
The words "destroy after use", if space allows.
The words “DEHP free” (or equivalent harmonised symbol).
Secondary package label includes the number of units.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
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 IIa device.
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management.
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Needle:
Material: stainless steel.
Sharp and silicone-coated for atraumatic insertion.
Mounted on a polymer base with two flexible fins that are used for anchoring and attaching the needle.
Thin needle walls.
Size selected: 25G (0.5x19 mm).
With a protective cap.
Butterfly wings:
For better fixations and handling.
Color code as per ISO 6009: orange
Material: medical grade plastic or PVC.
The external diameter (mm and gauge): Visible on the wings.
Tube:
Material: DEHP free polyurethane (PUR).
Soft, flexible.
Length: approx. 150-300 mm.
ending in a female Luer connector fitted with a stopper allowing an infusion set to be connected.
Connector:
Female Luer.
Usually interlocking that permits the attachment of an infusion set.
Intended use:
Sterile scalp vein needle to be introduced into a peripheral vein for infusing fluids and administering IV drugs.
Scalp vein needle are for short duration use, for longer duration use, it is preferable to use IV Cannula, which causes less irritation to the veins.
The needle should be held in the correct position by suitable dressing, allowing the observation of the site of insertion, and providing efficient barrier against infection.
The selected sizes are the most commonly used:
- 21G (0.80 x 19 mm) green, for adults.
- 25G (0.50 x 19 mm) orange, for children.
Safety process: The needle is for single use only. When inserting a needle: use aseptic techniques.
Supplied with:
Manufacturer’s instructions for use may be printed onto the primary packaging or provided on a separate insert.
Languages: English, Spanish and French.
Packaging and Labelling:
Primary packaging:
One (1) scalp vein needle unit packed in individual sterilised peel-pack.
Secondary packaging:
One (1) carton box of fifty (50) scalp vein needle units to blister packs.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words "for single use" (or equivalent harmonised symbol).
The words "check the package integrity before use", or similar warning.
The words "destroy after use", if space allows.
The words “DEHP free” (or equivalent harmonised symbol).
Secondary package label includes the number of units.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
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 IIa device.
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $4.38 |
