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Smiths new blood collection system receives 510(k) clearance

Smiths Medical : 30 January, 2008  (New Product)
Smiths Medical has received 510(k) clearance from the US Food & Drug Administration (FDA) for its Saf-T Closed Blood Collection System that is used for 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:

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

- 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.”
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