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unifine pentips unifine pentips plus

Owen Mumford

Summary: Unifine Pentips are pen needles used for subcutaneous injections, commonly utilized by patients with diabetes for insulin administration. They are designed for ease of use and comfort.

FDA Clearance Information

Pathway 510K
Decision Date June 24, 2016
Product Code FMI
Device Class Class 2
Evidence 0 studies

The Unifine Pentips by Owen Mumford were cleared through the FDA 510k pathway on June 24, 2016. It is a Class 2 medical device under product code FMI.

What It Is

Unifine Pentips are pen needles designed for delivering subcutaneous injections, primarily insulin. They feature a thin, sharp needle to minimize discomfort during injection. The device is compatible with most insulin pens, offering a convenient and effective solution for patients requiring regular insulin administration.

Clinical Applications

Unifine Pentips are predominantly used in endocrinology and primary care settings for patients with diabetes who require insulin therapy. They are suitable for both adult and pediatric populations, providing a reliable option for daily insulin injections. The device is also used in other clinical scenarios where subcutaneous injections are necessary.

Indications for Use

The FDA indications for Unifine Pentips include use in patients requiring subcutaneous injections, such as those with diabetes needing insulin. It is intended for use with compatible pen devices.

Practical Considerations

Unifine Pentips come in various needle lengths and gauges to accommodate different patient needs and preferences. They are designed for single use and should be disposed of properly after each injection. Clinicians should ensure compatibility with the patient's insulin pen.

Related Literature

The linked study compared the user performance and experience of the Nucleus Pen with commercially available pen needles. Although specific findings are not detailed, such studies typically assess ease of use, comfort, and user satisfaction. Limitations may include a small sample size or lack of diverse patient demographics.

Frequently Asked Questions

What is Unifine Pentips used for?

Unifine Pentips are used for administering subcutaneous injections, primarily insulin, in patients with diabetes.

What specialties typically use this device?

Endocrinologists and primary care physicians commonly use this device for managing diabetes.

What are the FDA-cleared indications?

Unifine Pentips are indicated for use in patients requiring subcutaneous injections, such as those with diabetes needing insulin therapy.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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