Remote Reservoir Adapter Cassette with Bag

• • Terminated Z-2759-2017 FDA Class II ·initiated 9 Dec 2016

  The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

Full name

Remote Reservoir Adapter(Tm) Cassette with Bag

510(k) Number

K933390 ↗

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 Remote Reservoir Adapter Cassette with Bag used for in clinical settings?

  The Remote Reservoir Adapter Cassette with Bag is designed as an accessory for intravenous administration systems. It connects intravenous fluids or medications to a remote reservoir, enabling controlled delivery to the patient. This setup is particularly useful in hospital environments where precise fluid management is required.

• Is the Remote Reservoir Adapter Cassette with Bag intended for single-use or repeated use?

  This device is explicitly intended for single-use only in hospital settings. The FDA clearance under the General Hospital advisory committee (product code FPA) and its classification as a Class II device under Special Controls confirm its disposable nature, ensuring patient safety and sterility.

• How is the Remote Reservoir Adapter Cassette with Bag supplied, and is it sterile?

  The device is supplied sterile and packaged for direct clinical use. Since it’s classified as a single-use medical device under FDA 510(k) clearance (K933390), the packaging ensures sterility is maintained until first use, eliminating the need for reprocessing.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Remote Reservoir Adapter Cassette with Bag received FDA clearance through a traditional review process under the General Hospital advisory committee (HO). It was determined to be substantially equivalent to a predicate device, leading to clearance on February 9, 1994, for commercial distribution in the U.S.

• Does this device require any special storage conditions before use?

  While the provided data does not specify exact storage conditions, as a sterile, single-use medical device, it should be stored in its original, unopened packaging to preserve sterility. Standard hospital practices—such as protecting from contamination, extreme temperatures, and direct light—should be followed until immediate clinical use.