Needle, scalp vein

last updated : 2018/12/31
Code Description Ind. price Ship. weight Ship. vol.
MINSNEEDV21
NEEDLE, SCALP VEIN, G 21, 0.8 x 19 mm, green CH 0,14 0,0051kg 0,064L Add
Controlled Temp : Storage +15 to +25°C
MINSNEEDV23
NEEDLE, SCALP VEIN, G 23, 0.6 x 19 mm, blue CH 0,15 0,0051kg 0,0558L Add
Controlled Temp : Storage +15 to +25°C
MINSNEEDV25
NEEDLE, SCALP VEIN, G 25, 0.5 x 19 mm, orange CH 0,11 0,0052kg 0,0576L Add
Controlled Temp : Storage +15 to +25°C

General information

For infusion of IV fluids, especially for children.

Specifications

Components & materials:

Needle: stainless steel

 

Tube: PVC or polyurethane (PUR)

 

Connector

 

Protective cap

 

Meets specification norms: EN-ISO 10555-1, EN-ISO 6009 and EN-ISO 20594-1

 

Needle:

 

- Length: between 10 and 30mm

 

- External diameter: between 0.3 and 2.1mm

 

- Mounted on a base, of variable size, with two flexible fins that are used for anchoring and attaching the needle.

 

- Usually triple bevelled.

 

- Silicone-coated to make insertion easier.

 

Tube:

 

- Supple

 

- Length: between 10 and 30cm

 

- Internal volume: between 0.15 and 2.5ml

 

Connector:

 

- Female Luer

 

- Usually interlocking

 

- Equipped with a bung; permits the attachment of an infusion set.

 

The sheath is open at both ends.

 

The needles are colour coded (visible on the fins), but the code has not yet been standardized.

 

The external diameter of the needle (mm and gauge), is inscribed on the fins.

 

Unit, sterile, disposable presentation.

 

21G: 0.8 x 19mm, green

 

23G: 0.6 x 19mm, blue

 

25G: 0.5 x 19mm, orange

Quality  requirements:

Must comply with Medical Device Directive 93/42/EEC or equivalent.

 

Meet following standards: 

 

EN-ISO 20594-1: Conical fittings taper for syringes, needles and certain other with a 6% (Luer) medical equipment - Part 1: General requirements (ISO 594-1:1986)

 

EN-ISO 10555-1: Sterile, single-use intravascular catheters - Part 1: General requirements

Unit presentation:

One scalp vein, single-use, sterile, individually peel packed in paper and/or plastic.

Primary packaging:

Labelling: Manufacture’s name and/or trademark, product description and reference number; "sterile" with sterilization method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.

Secondary packaging:

Protected unit, one (1) box 50- or 100-unit presentation; labelling is the same as that of the primary packaging.

 

Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).

Transport packaging:

Labelling is the same as secondary packaging with product-specific transport and storage instructions, when applicable, and quantity of secondary packages.