Remote Reservoir Adapter Cassette W/Bag Spike

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K895046 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Pharmacia Deltec, Inc. →

• What is the primary purpose of the Remote Reservoir Adapter Cassette with Bag Spike in a hospital setting?

  This device acts as a connector between intravenous infusion bags and remote reservoir systems, enabling controlled fluid administration. It’s specifically designed to integrate with intravenous infusion setups, ensuring compatibility while allowing for remote fluid management in clinical environments.

• Is this device meant for reuse, or is it intended for single-use only?

  The Remote Reservoir Adapter Cassette with Bag Spike is explicitly designed for single-use only. This aligns with standard medical device protocols to maintain sterility and patient safety, especially in clinical settings where contamination risks must be minimized.

• How is the device supplied, and what precautions should be taken during handling?

  The device is supplied sterile and requires adherence to standard medical device handling protocols. Since it’s classified under Class II Special Controls, it must be stored and used in accordance with manufacturer guidelines to preserve sterility and ensure safe administration in hospital settings.

• Are there any special storage requirements for this device?

  While the provided data does not specify exact storage conditions, as a sterile, single-use medical device, it should be stored in a clean, dry environment protected from contamination. Standard medical device storage practices—such as avoiding extreme temperatures or direct sunlight—should be followed to maintain its integrity until use.