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Nipro Blood Collection Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992699

by Nipro Medical Corp.

Identifiers

510(k) Number
K992699 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nipro Blood Collection Needle is a venipuncture needle designed for blood collection procedures, classified under the phlebotomy needle category. It features a three-beveled, siliconized tip to facilitate smooth vein insertion, reducing patient discomfort during sampling. This device is intended for use with multiple blood tube samples, ensuring efficient and accurate phlebotomy.

Supplied sterile and intended for single-use, the needle is compatible with blood tube holders for secure attachment during venipuncture. It is manufactured by Nipro Medical Corp. and holds an FDA 510(k) clearance under the General Hospital advisory committee, with a Traditional review pathway. Available in multiple gauges (20, 21, and others), it adheres to standard phlebotomy protocols and regulatory requirements for blood collection devices.

Frequently asked questions

What is the Nipro Blood Collection Needle designed for?

The Nipro Blood Collection Needle is specifically designed for blood collection procedures, commonly known as venipuncture. Its three-beveled, siliconized tip reduces friction during vein insertion, minimizing patient discomfort and improving the efficiency of blood sampling. This design is particularly useful when multiple blood tube samples are required, as it ensures a smoother and more accurate phlebotomy process.

How is the Nipro Blood Collection Needle supplied and intended for use?

The needle is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination between uses. It is compatible with standard blood tube holders, allowing for secure attachment during venipuncture, which helps maintain stability and accuracy during the procedure.

What gauges are available for the Nipro Blood Collection Needle?

The Nipro Blood Collection Needle is available in multiple gauges, including 20 and 21, among others. The choice of gauge depends on the patient’s vein size and the specific requirements of the blood collection procedure. Larger gauges (e.g., 20) are typically used for easier access in smaller veins, while smaller gauges (e.g., 21) may be preferred for more delicate procedures or patients with fragile veins.

Is the Nipro Blood Collection Needle reusable or single-use?

The Nipro Blood Collection Needle is explicitly designed for single-use only. Single-use devices are critical in medical settings to prevent infection transmission and ensure patient safety. Reusing needles can introduce risks such as contamination, infection, or injury, which is why regulatory standards and best practices mandate their disposal after one use.

How should the Nipro Blood Collection Needle be stored?

While the provided data does not specify storage conditions, standard practice for sterile, single-use medical devices like this needle typically involves storing them in a clean, dry environment protected from direct sunlight, extreme temperatures, and moisture. The packaging should remain intact until use to maintain sterility. Always follow the manufacturer’s instructions or any additional guidelines provided in the product documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BLOOD COLLECTION NEEDLE - Nipro, Nipro – Wikipedia, STANDARD BLOOD COLLECTION SET - Nipro, NIPRO CORPORATION - Live longer. Live better., Nipro Blood Collection Needles | Multi-Gauge Sterile Phlebotomy

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corp.

Sources (1)

  • FDA 510(k) K992699 24 fields · synced Oct 1, 2026