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Monoject 60ml Syringe (luer Lock Tip +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131641

by Nipro Medical Corporation

Identifiers

510(k) Number
K131641 FDA 510(k)
FDA Product Code
FMF FDA 510(k)
Models / Variants
luer Lock Tip FDA 510(k)
Luer Slip Tip FDA 510(k)
Catheter Tip FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Monoject 60 mL Syringe is a disposable, single-use injection device designed for the precise administration or withdrawal of fluids. It features a polypropylene barrel and plunger rod with graduated markings, ensuring accurate dosing while maintaining compatibility with various medical connectors.

Supplied in sterile packaging, this syringe is intended for use in clinical settings such as hospitals and medical facilities. Available in individual or bulk configurations, it adheres to FDA 510(k) clearance (K131641) and is manufactured without DEHP or natural rubber latex. The device is classified under product code FMF and is designed for one-time use only.

Frequently asked questions

What types of medical connectors can the Monoject 60 mL syringe be used with, and why is this important for clinical settings?

The Monoject 60 mL syringe is designed with three interchangeable tip options: Luer Lock, Luer Slip, and Catheter Tip. This versatility ensures compatibility with a wide range of infusion sets, needles, and medical devices commonly used in hospitals and clinical settings. The Luer Lock tip provides a secure connection to prevent accidental dislodgment, while the Luer Slip and Catheter Tip options offer flexibility for different procedural needs, such as flushing catheters or administering fluids through specialized connectors.

Is the Monoject 60 mL syringe suitable for repeated use, and what precautions should be taken during storage to maintain its integrity?

The Monoject 60 mL syringe is explicitly designed for single-use only, meaning it must not be reused after a single administration or withdrawal of fluids. To maintain sterility and functionality, it should be stored in its original, unopened sterile packaging until use. Exposure to moisture, extreme temperatures, or contamination can compromise the device’s integrity, so it’s important to keep it in a clean, dry environment away from direct sunlight or sources of heat.

How does the absence of DEHP and natural rubber latex in the Monoject 60 mL syringe benefit patients and healthcare providers?

The Monoject 60 mL syringe is manufactured without DEHP (di(2-ethylhexyl) phthalate) and natural rubber latex, which reduces the risk of allergic reactions or sensitivities in patients who may be sensitive to these materials. This design choice aligns with best practices for minimizing exposure to potential allergens in clinical settings, ensuring safer use for a broader range of patients, including those with latex allergies or phthalate sensitivities.

What packaging options are available for the Monoject 60 mL syringe, and how might this affect purchasing decisions for hospitals or medical facilities?

The Monoject 60 mL syringe is available in individual packaging (for single-use convenience) as well as bulk configurations, which are ideal for larger medical facilities or high-volume settings. Bulk packaging can streamline inventory management and reduce waste by providing ready access to multiple syringes at once, while individual units offer flexibility for smaller procedures or point-of-care use. This dual availability ensures hospitals can choose the option that best fits their operational needs.

What should clinicians know about the syringe’s graduated markings and how they contribute to accurate fluid administration?

The Monoject 60 mL syringe features graduated markings on the polypropylene barrel, allowing clinicians to measure and administer fluids with precision. These markings help ensure accurate dosing, which is critical for procedures requiring exact volumes, such as medication administration, irrigation, or fluid resuscitation. The clarity and consistency of the markings reduce the risk of human error, supporting safer and more reliable clinical outcomes.

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: Monoject 60ml Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip), 60 mL Standard Syringe with Luer-Lock Tip - Preferred Medical, Cardinal Health Monoject 60mL Syringes - Cath, Reg, Luer, Toom ..., Monoject™ Syringes - Cardinal Health

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA 510(k) K131641 24 fields · synced Sep 19, 2026