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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

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

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

Product Details:
Place of Origin: China
Certification: ISO13485, MDR CE, US FDA, US FDA 510K, UK MHRA
Payment & Shipping Terms:
Minimum Order Quantity: 100,000 Pcs
Price: Negotiable
Packaging Details: 100 Pcs/Box, 40 Boxes/Ctn
Delivery Time: 30 Working Days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000 Pcs Per Day

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

Description
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
High Light:

CE 31 gauge 8mm needle

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FDA510K easy comfort pen needles

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FDA510K 31 gauge 8mm needle

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 5mm 0FDA 510K Approved Single End Protective Safety Insulin Pen Needles 30G 5mm 1

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 2

 

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 3


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.

 

Contact Details
Suzhou Summit Medical Co., Ltd

Contact Person: Cage Wan

Tel: 86-18550761548 / 86-18501567726

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