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[China]
Trade Verify
Address: Room 1517, Building C, Fanhua Commercial Center, No. 4555 Renmin Road, Yuanhe Street, Xiangcheng District, 215131 Suzhou, Jiangsu, China
Contact name:Cage Wan
Suzhou Summit Medical Co., Ltd |
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Verified Suppliers
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【Safety Pen Needle Purpose】
Retractable insulin pen needles are sterile, single use needles intended for using with pen injector devices for the injection of drugs. Safety insulin pen needles can be used with insulin pens that meet the requirements of ISO 11608-1, for example: Autopen, Flexpen, Novopen Echo / Novopen 4, Humapen Ergo / Humapen Luxura / Humapen Memoir, KwikPen, Solostar, ClickStar, SymlinPen etc.
【Safety Pen Needle Specifications】
| Type | Safety Pen Needle |
| Material | PE+PP+Stainless Steel |
| Gauge | 30G-32G |
| Length | 4MM-12MM |
| Sterilization | Gamma or Electron Beam Irradiation |
| OEM | Available |
| HS Code | 9018321000 |
| Shelf Life | 5 Years |
| Package | 100 Pcs/Box, 40 Boxes/Ctn |
| Carton Size | 55*35.5*35.8cm |
| G.W. | 15 KGS Per Carton |
| Certificates | ISO13485(TUV), MDR CE (TUV), US FDA, US FDA 510K, UK MHRA |
| Intended Use | Match with insulin pen for insulin injection to lower the blood sugar level. |
【Safety Pen Needle Features】
Safety
Shield automatically locks after injection to help reduce the risk
of accidental needlesticks.
Metal tabs provide visual confirmation that the safety feature is
activated.
Comfort
Broad shield diameter reduces pressure on the patient's skin.
Pen needle is hidden from view for a less intimidating experience.
Single-Handed Technique
Highest level of protection with single-handed technique.
Flexibility
Flexible to work with all pen injectors for diabetes
treatment.
【Safety Pen Needle Compatibility】
The diabetic safety needles match with wide range of insulin pens in the market:
FlexTouch® Novo Nordisk
FlexPen® Novo Nordisk
NovoPen®Echo Novo Nordish
NovoPen® 4 Novo Nordish
NovoPen® 5 Novo Nordisk
Lantus SoloStar®
OptiPen® Pro 1 Sanofi
KwikPen® Humalog
Liprolog® Eli Lilly
Huminsulin® Eli Lilly
HumaPen® Luxura ™ Eli Lilly
HumaPen® Luxura ™ HD Eli Lilly
HumaPen® MEMOIR ™ Eli Lilly
Exenatide Pen Byetta
Autopen® Classic Owen Mumford
Autopen® 24 Owen Mumford
Omnican® Pen 31B.Braun
Ypsopen® Ypsomed
OptiClik® Ypsomed
BerlinPen® Areo Berlin-Chemie
BerlinPen® Areo 2 Berlin Chemie
BerlinPen® 302 Berlin Chemie
Tactipen® Haselmeier
and many others
【Safety Pen Needle IFU】
【Safety Pen Needle Storage】
The diabetic pen needles should be stored in a well-ventilated room and kept away from light and moisture and corrosive gases.
【Safety Pen Needle Warning】
1. The retractable pen needles should be used immediately
after the seal is removed. Please do NOT use the pen needle if the
seal is damaged or broken previously.
2. The safety insulin pen needle is sterilized by irradiation
and is designed for single use. Re-use may lead to mechanical
malfunction and potential microbiological contamination.
3. Please read the user manual carefully before use.
4. Insulin injection needle is only intended for using with
insulin injection pen.
5. Keep insulin pen needles out of the reach of children.
6. Do not share your needles with other people which can lead to
the transmission of viral diseases. You may give other people a
serious infection or get a serious infection from them.
7. Do not insert the pen needle at an angle towards your fingers,
this may result in a needle-stick injury.
8. In the event of any serious adverse event, please report to the
manufacturer and the competent authority.
【Safety Pen Needle Production】
We're adopting the most advanced production technology and strict quality inspection to guarantee the stable quality.
- Auto-Manufacturing Line;
- Own Sterilizer: SAL10, EO Gas, BI Test, CI Test, Sterility Best, ISO1135
- Clean Room (Class 100,000) by the installation with HEPA Filter in the last stage of process
- Air Control: Bioburden Test, ISO 11737-1
- Environmental Control (ISO13485:2016, CE 0197, 21CFR 820, MDSAP)
