Description

The 12ML ENFit Syringe is a specialized tool designed for the precise delivery of medication, nutrition, and fluids through enteral feeding tubes. Its design caters to a wide range of patients, including neonatal, pediatric, and adult users, making it suitable for both clinical and home care environments.

Key Features

• Secure Connection: Equipped with a female ENFit® connector, this syringe adheres to ISO 80369-3 standards, ensuring secure connections and preventing misconnections with other medical devices.
• Clear Markings: The syringe features clear volume markings with major gradients at 1 mL and minor gradients at 0.2 mL, allowing for accurate measurement and administration.
• Single Use Design: Intended for single use, enhancing safety and hygiene in medical settings.

Material and Compatibility

• Material Composition: Constructed from USP Class VI medical grade polypropylene for the barrel and plunger, and medical grade silicone for the gasket. The syringe is free from latex, BPA, DEHP, and PVC, reducing the risk of allergic reactions and ensuring patient safety.
• Compatibility: Compatible with ENFit male connectors on feeding tubes and medication ports. Some models are also compatible with enteral syringe drivers.

Additional Options

• Tip Cap and Low Dose Tip: Includes a hands-free tip cap for aseptic technique and a low dose tip option for precise dosing of small volumes.
• Color and Sterility Variants: Available in various colors such as Orange, Purple, and Amber, and in both sterile and nonsterile versions.

Safety and Compliance

• Non-Toxicity: Tested to be non-cytotoxic, non-sensitizing, non-irritating, and systemically non-toxic. Complies with ISO 80369-3, ISO 7886-1, ISO 13485, and ISO 10993-1:2018 standards.
• CE Marked: Classified as a Class IIa medical device, ensuring adherence to stringent safety and quality standards.

Packaging and Storage

• Packaging Options: Sterile syringes are individually sealed with a case containing 200 units, while nonsterile syringes are packaged in bags with a case containing 500 units.
• Storage Instructions: Store in a clean, dry place at room temperature, away from heat and radiation.

Reusability and Prescription Use

Some models, such as the NeoMed ENFit O-ring Syringe, offer reusability up to 20 times when hand washed. Certain versions are intended for prescription use only, and the syringe is not designed for drug storage.

Common Applications

Ideal for enteral feeding, medication administration, water flushes, and fluid measurement, the 12ML ENFit Syringe is a reliable and compliant device that meets the needs of healthcare providers and patients alike.