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Dana 3CC Syringe Insulin Reservoir

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K071418

by Sooil Development Co., Ltd.

Identifiers

510(k) Number
K071418 FDA 510(k)
FDA Product Code
MRZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dana 3cc Syringe Insulin Reservoir is a disposable reservoir designed as an accessory for insulin infusion pumps. Classified under infusion pump accessories, it serves as a reservoir to store insulin and deliver it via infusion sets at a controlled rate determined by the pump. With a capacity of 3 milliliters and a 300-unit insulin capacity, it is intended for use with insulin pumps to manage insulin delivery over extended periods.

This reservoir is supplied as a single-use, sterile plastic syringe featuring a plunger with a groove for attachment to the pump’s linking screw. It connects to the pump’s motor via a screw mechanism, enabling linear movement for insulin release. The device is regulated under FDA 510(k) clearance, MDD, and MDR compliance, and is intended for use in general hospital settings. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What is the primary purpose of the Dana 3cc Syringe Insulin Reservoir, and how does it work with an insulin pump?

The Dana 3cc Syringe Insulin Reservoir is designed as a disposable accessory for insulin infusion pumps to store and deliver insulin over extended periods. It holds up to 3 milliliters of insulin (equivalent to 300 units) and connects to the pump via a screw mechanism. The reservoir’s plunger moves linearly when driven by the pump’s motor, allowing precise, controlled insulin delivery through an attached infusion set at the rate programmed by the pump.

Is the Dana 3cc Syringe Insulin Reservoir intended for reuse, or is it meant to be used only once?

The Dana 3cc Syringe Insulin Reservoir is explicitly labeled as a single-use device. After use, it should be discarded to maintain sterility and prevent contamination, adhering to standard sterile medical device protocols.

What storage and handling precautions should be taken for the Dana 3cc Syringe Insulin Reservoir?

Since the reservoir is sterile and disposable, it should be stored in a clean, dry environment following standard sterile medical device protocols. Avoid exposure to moisture, extreme temperatures, or contamination before use. Once opened or prepared for use, it must be used immediately and then discarded.

How does the reservoir attach to an insulin pump, and what features facilitate this connection?

The reservoir attaches to the insulin pump via a screw mechanism on its plunger, which aligns with the pump’s linking screw. The plunger includes a groove designed specifically for this connection, ensuring a secure and stable attachment. This allows the pump’s motor to drive the plunger’s linear movement for insulin delivery.

What regulatory compliance does the Dana 3cc Syringe Insulin Reservoir meet, and where is it primarily intended for use?

The device complies with FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) standards. It is classified under infusion pump accessories and is intended for use in general hospital settings, as indicated by its regulatory filings and advisory committee classifications.

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: Dana Diabecare IIS | Insulin Pump | SOOIL Mall, Dana Diabecare IIS | Insulin Pump | SOOIL Mall, SOOIL Development

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sooil Development Co., Ltd.

Sources (2)

  • FDA 510(k) K071418 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026