Smiths Medical Receives 510(k) Clearance On Saf-T Closed Blood Collection System(R) Devices

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 01 Feb 2008 - 3:00 PDT

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Smiths Medical, ASD, Inc., a leader in high-quality medical devices and products, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Saf-T Closed Blood Collection System® for use in syringe blood draw and transfer applications. Configurations address winged vein access as well as Luer access to a newly placed peripheral IV catheter.

As an extension of the company's Saf-T Wing® Blood Collection Devices, the Saf-T Closed Blood Collection System® is similar in design to Saf-T Wing® Blood Collection Set, but accommodates either a male Luer connector or a Saf-T Wing to access the vein. Both configurations incorporate a female Luer connector for sample syringe attachment. The Saf-T Closed Blood Collection System® devices require minimal manipulation of the Luer connectors once the initial set up is completed, resulting in lower risk for sample contamination. The product is available in two configurations, both of which incorporate a female Luer for syringe attachment, a permanently attached Saf-T Holder® device for blood transfer to blood collection tubes and a clamp to direct the blood:

1. Bifurcated with male Luer connector for attachment to a newly placed peripheral IV catheter.

2. Bifurcated with Saf-T Wing® device to access the vein.

"We have designed our new Saf-T Closed Blood Collection System® to safely meet the needs of patients that require a controlled syringe draw for blood collection and transfer," said Regina McIntosh, Vice President, Sales and Marketing of Smiths Medical Critical Care. "We are particularly pleased that our design has successfully lowered the amount of manipulation of the Luer connectors after the initial set up. This, we believe, can potentially help lower the associated risk of sample contamination."

About Smiths Medical

Smiths Medical is a leading supplier of high-quality medical devices and products to global markets and is comprised into three product groupings: Safety Devices, Vital Care and Medication Delivery & Patient Monitoring. The company designs, manufactures and sells its products to hospitals and other healthcare providers, as well as to alternate care, including home care worldwide. Smiths Medical is part of the global technology company, Smiths Group, a world leader in the practical application of advanced technologies. Smiths Group is listed on the London Stock Exchange.

Smiths Medical