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FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm

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FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm

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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

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FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm

【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】

FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mmFDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm

The red indicator shows after injection. It means the insulin injection needle can't be used again.

【Safety Pen Needle IFU】

FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm

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)

FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm


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.


Product Tags:

CE 31 gauge 8mm needle

      

FDA510K easy comfort pen needles

      

FDA510K 31 gauge 8mm needle

      
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