Categories | Safety Pen Needle |
---|---|
Certification: | ISO13485, MDR CE, US FDA, US FDA 510K, UK MHRA |
Place of Origin: | China |
MOQ: | 100,000 Pcs |
Price: | Negotiable |
Payment Terms: | L/C, T/T, Western Union |
Supply Ability: | 500,000 Pcs Per Day |
Delivery Time: | 30 Working Days |
Packaging Details: | 100 Pcs/Box, 40 Boxes/Ctn |
Item Name: | FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm |
Gauge: | 30G |
Length: | 5mm |
Color: | Light Blue |
Material: | PE+PP+Stainless Steel |
Needle: | Triple Beveled Tip, Silicon Coating |
Shelf Life: | 5 Years |
Classification: | Medical Device Class III |
Sterile: | Gamma Or Electron Beam Irradiation |
Benefits: | Safe, Convenient, Comfort, Compatible |
【Safety Pen Needle Descriptions】
Diabetic safety needles are sterile, single use needles intended for using with pen injector devices for the injection of drugs. It 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 Needles |
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. | 15Kgs/Ctn |
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 Advantages】
SAFE
Automated shielding mechanism ensures needle is covered before and
after use;
Concealed pen needle design helps to relieve patient’s anxiety;
Single-use design prevents accidental needle stick injuries and reuse of the device for safety of patients and healthcare professionals;
All retractable insulin pen needles are irradiation sterilized and protected with outer cover and sterility peel-back tab.
SIMPLE
Easy to use, intuitive handling with no pre-loading required;
Clear shield with optimized skin contact area allows for improved visibility of insulin flow during priming and precise positioning on the injection site;
Safety mechanism engagement can be easily recognized by ‘’Click’’ sound when the needle is fully inserted into the skin.
COMFORTABLE
Electro-polished, silicone-coated, ultra-thin needles guarantee
enhanced user comfort;
Easy flow cannula minimizes time of insulin delivery;
Smooth and quick insert/retract mechanism makes the injection a barely-noticeable experience;
Ergonomic design with ribbed housing ensures comfortable grip, secure attachment onto the pen injector, as well as easy removal.
UNIVERSAL
Universal design for compatibility with most injection pens
available on the market;
Tight fit prevents leakages and medication loss;
Rigorously tested per international standards for fit, functionality and reliable performance.
【Safety Pen Needle Details】
The red indicator shows after injection. It means the insulin injection needle can't be used again.
【Safety Pen Needle IFU】
Step 1: Remove the protective seal.
Step 2: Screw the needle onto the pen injector. Keep the needle
straight without any damages.
Step 3: Remove the pen needle outer cover and dispose it into an
appropriate container.
Step 4: Upward the needle, flick the pen injector to float the bubbles to the needle top, press the injection button until the liquid is discharged from the needle tip.
Step 5: Make an injection per physician's advice. After injection,
keep the insulin needle under the skin for at least 6 seconds
before pulling out.
Step 6: Discard the used diabetic pen needle into an appropriate
container.
【Safety Pen Needle Storage】
The diabetes needle should be stored in a well-ventilated room and kept away from light and moisture and corrosive gases.
【Safety Pen Needle Warning】
1. The diabetic pen needle 30G 5mm 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. This insulin safety 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. The painfree pen needle is only intended for using with insulin
injection pen.
5. Keep insulin needle tip 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 injection 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 FAQ】
Q1: What are the advantages by comparison with the other Safety Insulin Needles?
A1: 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)
Q2: Are free samples available before official mass purchasing?
A2: We can support you free samples, and you just need to bear the
courier charge.
Q3: Are we able to register your Safety Pen Needles in our MOH to
get the importation permission?
A3: Yes. We can provide you all registration meterials like
samples, package lables, certificates and technical documents, which enable the registration smoothly. We have all certificates
like FSC, ISO13485, CE, DOC, FDA 510K. And technical files like COA, COS, Clinical Study, Risk Analysis,
Biocompatibility Test Reports etc.