Piston Syringes

• • Terminated Z-2008-2019 FDA Class II ·initiated 1 Feb 2019

  The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

510(k) Number

K944757 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What are BD Piston Syringes used for in clinical settings?

  BD Piston Syringes are designed for precise aspiration, measurement, and delivery of liquids, making them ideal for tasks such as blood collection, medication administration, and fluid transfer in clinical environments like hospitals and diagnostic laboratories. Their piston-driven mechanism ensures accurate volume control, which is critical for procedures requiring precise dosing or maintaining sample integrity.

• Are BD Piston Syringes sterile and how are they packaged?

  Yes, BD Piston Syringes are supplied sterile to ensure aseptic handling. They are individually packaged to maintain sterility and prevent contamination before use.

• Are BD Piston Syringes intended for single-use or reuse?

  These syringes are explicitly designed for single-use only. This design choice minimizes the risk of cross-contamination and ensures patient safety by preventing reuse, which could compromise sterility and accuracy.

• What is the FDA’s classification and regulatory pathway for BD Piston Syringes?

  BD Piston Syringes fall under the FDA’s classification as Syringes, Piston Type, and are categorized under the product code FMI within the General Hospital advisory committee. They were granted clearance through the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) in 1995.

• What sizes or models are available for BD Piston Syringes?

  The provided data does not specify exact sizes or model variations for BD Piston Syringes. For precise details on available volumes or model references, refer to the manufacturer’s product documentation or catalog.