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The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

The Steripath® Micro Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use. The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available: | Steripath®<br>Micro Kit<br>Model<br>Number | ISDD® | Inlet Accessory | Outlet Accessory | |--------------------------------------------|--------|----------------------------------------------------------------------|--------------------------------------------------------------| | 4005-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 5ml<br>Becton Dickinson<br>Model 301027<br>K980987 | | 4010-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 10ml<br>Becton Dickinson<br>Model 301029<br>K980987 | | 4020-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>K980987 |