NEEDLE FOR INSULIN PEN 31GX4MM DISPOSABLE,NEEDLE STERILE, WITH TRIPLE BEVELLING. INDIVIDUAL BLISTER PACK. RAYS ITALY.

Needle  For Insulin Pen 31Gx4Mm Micropen

Product name: Micro/Pen
Destination of use: Sterile, disposable, insulin pen needle, from 29G to 33 G for insulin administration.
Description : Sterile, disposable, insulin pen needle. Non toxic, non pyrogenic, fixed needle, suitable for all the insulin pens on sale.
· Thin wall for reducing the injection pain and injection duration,
· bigger inner cannula for a quicker insulin flow
· polypropylene needle cap
· color code inner cap, for an easy gauge identification
· hermetic paper with Gauge color
· triple beveling needle, lubricated with silicon oil in quantity less than
0,25 mg/cm2 of inner area.
Latex free: the device is completely latex-free, thus eliminating any risk of allergic reactions to latex
Phthalates: the device is DEHP free.
Sterilization method: Ethylene oxide Sterilization (EtO)
Gas residual ≤ 2 ppm
Validity sterilization: 5 years from manufacturing date
Storage: Keep in dry and cool place, away from direct sunlight or heat sources, at temperatures below 50°C.
Measures: from 29G to 33 Gauge in color coding and with the following codes:

PRODUCT CODE GAUGE NEEDLE LENGHT mm INNER CAP COLOR
100-PEN29G12 29 12 mm Red
100-PEN30G8 30 8 mm Yellow
100-PEN31G4 31 4 mm Light blue
100-PEN31G5 31 5 mm Violet
100-PEN31G6 31 6 mm Blue
100-PEN31G8 31 8 mm Orange
100-PEN32G4 32 4 mm Light green
100-PEN32G5 32 5 mm Pink
100-PEN32G6 32 6 mm Sky blue
100-PEN33G4 33 4 mm Green

Packaging : Individual blister pack composed of medical paper that guarantees maximum security in terms of sterilization and prevents the formation of scraps of paper during the opening operation. On the package there are the sterilization date, expiry date and the batch number that are also written outside the box which also shows the needle quantity (n. 100 pieces) and needle size.

The carton contains 12 dispensers (n.1.200 pieces).
Usage and Instructions: Single use. Verify the integrity of the package before use. Do not use if package is damaged. Check the information paper for instructions for use. Dispose of it properly.
Disposal: Disposal has to be conducted according to the National regulations. The incineration or disposal should be carried out under controlled conditions. If the product has not been in contact with infectious agents or other hazardous materials produces no toxic residue.
Conformity: In compliance to standards:
ISO 13485:2003/AC:2007
ISO 11608-2:2012
EN 556-1:2006
EN ISO11135-1:2007
ISO 594-2:1986
ISO 594-2:1998
ISO 9626:2001
ISO 7864:1995
ISO 6009:1992
Category: Medical device, class IIa in conformity with the EEC Directive 43/92 and following amendments.