Gen1 Needle Free Connector - Negative Pressure, Metal Free, ISO 80369-7

The Gen1 needle free connector (also called a needleless connector or needle-free access port) is a negative pressure, entirely metal-free IV line connector developed and manufactured by Chi Feng Co., Ltd. in Taiwan. It lets clinicians connect and disconnect an infusion line without a needle at the access point, and it is built from only three components, which keeps the failure rate low. Gen1 is covered by patents granted in the USA, EU, Taiwan, China and Japan.

Chi Feng supplies Gen1 as a component or sub-assembly to medical device manufacturers. Market clearance for the finished device is held by the finished device manufacturer. If you already hold a 510(k) or CE certificate and need a qualified component or a finished assembly, contact us to discuss cooperation.

Gen1 Technical Specifications

Specification values are taken from the Chi Feng 2025 product catalog. Test reports are available on request or under NDA.

Which Generation Fits Your Application

Chi Feng manufactures three needle free connector families. They are not replacements for one another; each is engineered for a different pressure behaviour and flow requirement. Use this table to select the right one for your set design.

Gen1 remains the widest configuration family of the three, with 12 variants covering luer, Y, straight, T-port, luer slip, burette cap and filtered types. See Gen2 Needle Free Connector and High Flow Rate Needle Free Connector for the other families.

Gen1 Model and Configuration Table

Custom colors and materials are available on request. Contact us for drawings and samples of any configuration.

Key Features

[Simple structure]: Built from only three components, which significantly reduces the chance of failure compared with multi-part valve designs.

[Standard compliant]: Complies with ISO 594 and ISO 80369-7, so it connects with any other product built to those standards. Minimal force is required to connect, while the design resists accidental disconnection from external force or internal pressure.

[Swabable surface]: The flat top face of the housing is designed to be wiped down before access. Fluorescein dye testing confirmed no dye residue remains on the swabable surface after disconnection and wiping.

[Metal free construction]: Housing, septum and internal parts contain no metal, which simplifies material declarations and avoids metal-related handling questions.

[Tested materials]: Housing and septum are medical grade polycarbonate and medical grade silicone, tested for biocompatibility, lipid resistance and alcohol resistance. The housing structure has passed blood compatibility testing.

[Pressure infusion capable]: Rated to 325 psi maximum pressure and 70 psi back pressure, suitable for high pressure infusion therapy.

Applications

• IV administration sets: gravity and pump driven infusion sets requiring a needle free access point.
• Extension lines and Y-site injection ports: 2.3mm, 3mm and 4mm tubing configurations for inline access.
• Burette sets: the 13C013 burette cap integrates a needleless valve directly into the IV bag or burette top.
• Vial access assemblies: the 15C007 combines a Gen1 connector with a mini vial adapter and 0.2 micron filter. See our Vial Adapter range.
• Veterinary infusion devices: the same ISO 80369-7 geometry applies to veterinary infusion set programs.
• OEM and ODM set assemblies: supplied as a component or sub-assembly for customers building their own branded infusion sets.

Regulatory Position and Documentation

Chi Feng manufactures components and sub-assemblies. Market clearance for a finished medical device is held by the finished device manufacturer, not by the component supplier. We support our customers' regulatory work with:

• ISO 80369-7 dimensional conformance information for luer geometry
• ISO 10993-1 biocompatibility test data
• Material declarations and bill of materials
• Manufacturing under a BSI certified ISO 13485:2016 quality system in an ISO class 8 cleanroom
• Sterilization validation support for EtO and Gamma through qualified partners

If you hold a 510(k), CE certificate or another market authorization and need a qualified component or a finished assembly, write to us and we will discuss the cooperation model, documentation package and tooling schedule.

OEM and ODM Service

Chi Feng has manufactured medical plastic components in Taiwan since 1988, with more than 20 years of needle free connector development. Our capability covers the full chain from drawing to finished component:

• In-house mold design and mold manufacturing, so tooling and production stay with one supplier
• Injection molding of medical grade polycarbonate, MABS, ABS, PP and silicone, including insert molding
• Automated assembly lines with AOI optical inspection for connector sub-assemblies
• ISO class 8 cleanroom assembly and packaging, with a dedicated measuring room for dimensional verification
• Product design and development support from concept through structural design, prototype tooling, validation and mass production
• Private label service including custom color, custom material, custom tubing bore and customer branded packaging

FAQ

What is the difference between a Gen1 and a Gen2 needle free connector?
Gen1 is a negative pressure connector rated to 200 activations and 150 mL/min flow. Gen2 is a neutral pressure design rated to 600 activations with 0.016 mL residual volume. They are engineered for different pressure behaviour and set requirements, not as replacements for one another.

Is the Gen1 connector compliant with ISO 80369-7?
Yes. Gen1 uses male and female luer slip and luer lock geometry per ISO 80369-7, so it mates with any other device built to that standard. It also complies with ISO 594.

What is the maximum pressure the Gen1 connector withstands?
325 psi maximum with 70 psi back pressure, per the current catalog specification. Use 325 psi for your design calculations.

Does Chi Feng hold FDA 510(k) clearance for the Gen1 connector?
Chi Feng supplies components and sub-assemblies. Market clearance for a finished device is held by the finished device manufacturer. If you hold a 510(k) and need a qualified component or a finished assembly, write to us to discuss cooperation.

How many times can the septum be activated?
The silicone septum is specified to return to a flat surface after 200 actuations. A cycle test report is available on request.

Does the connector contain any metal parts?
No. The Gen1 series is entirely metal free. The housing and internal parts are medical grade polycarbonate, MABS or ABS with a medical grade silicone septum.

What is the residual volume and why does it matter?
Gen1 holds 0.3 mL inside the connector. Residual volume matters when you are calculating flush volume and drug delivery accuracy for your set design. If your application needs a lower figure, Gen2 holds 0.016 mL.

Which tubing sizes are available?
Y connectors for 2.3mm, 3mm and 4mm OD tubing; straight connectors for 2.3mm and 4mm OD; a 4.4mm OD version for 6.8 to 7.2mm ID; a T port for 6.8mm and a T connector for 2.3mm; plus luer, luer slip, burette cap and filtered vial adapter types.

Is the product supplied sterile, and which sterilization methods apply?
Sterilization depends on the customer. We supply non-sterile for your own processing, or EtO or Gamma sterilized to your specification.

Do you offer OEM, ODM and private labeling?
Yes. We provide custom color, custom material, custom tubing bore, customer branded packaging and full tooling development from your drawing.

What is the minimum order quantity?
MOQ depends on the model, packaging format and whether sterilization is included. Contact us with your target quantity and destination market for a formal quotation.

Learn More in Our Knowledge Hub

Gen1 Needleless Connector: A Safe and Efficient Infusion Solution
Needle Free Connectors: full range overview

Your Device. Our Component.
Twelve Gen1 configurations, ISO 80369-7 luer geometry, metal free construction, EtO or Gamma sterilization, and OEM/ODM service including custom color, material and private label packaging. Manufactured in Taiwan under a BSI certified ISO 13485:2016 system since 1988.

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Chi Feng Co., Ltd. - Established in Taiwan since 1988 | Medical plastic component manufacturer | BSI ISO 13485:2016 certified, ISO class 8 cleanroom
Sales: Pei Tsai - pei@e-elect.com.tw | Kevin Tsai - kevintsai@e-elect.com.tw