Abstract: A device and method is provided for separating heavier and lighter fractions of a fluid sample. The device includes a plurality of constituents comprising a container and a composite element in the container. The composite element is a separator comprising at least two components and more particularly an elastic portion and a plug member. A fluid sample is delivered to the container and the device is subjected to centrifugation whereby the centrifugal load causes the elastic portion of the separator to deform so that the separator migrates into the fluid sample and stabilizes between the heavier and lighter fractions of the fluid sample. The elastic portion of the separator will resiliently return to its initial configuration upon termination of the centrifugal load such that the elastic portion sealingly engages the container and separates the heavier and lighter fractions of the fluid sample.

Abstract: The present invention is a label system and method for label alignment and placement on a container. The label system includes a first label or a container whereby the first label includes alignment symbology and a second label having an alignment area corresponding to the alignment symbology of the first label. The second label is positioned on the container whereby the alignment area of the second label is aligned with the alignment symbology of the first label. Visibility enhancement indicia may be provided adjacent the alignment area to increase the visibility of the alignment area to the user. Other indicia may be used to align the container in a holder for bar code scanning.

Abstract: A system, method and computer readable medium of instructions are provided which are useful for determining whether an evaluation testing method or device is clinically equivalent to a reference testing method or device. The report can include a modified mean difference plot, a variability chart, confidence intervals for bias and a plot of the intervals. A graphical user interface is provided to allow data associated with the reference and evaluation methods or devices to be identified. A level of variance in the reference method is determined. An observed bias between the evaluation methods or devices and the reference methods or devices is calculated. A confidence interval for the bias is calculated. The biases between the evaluation methods or devices and reference method or device is compared relative to the level of variance in the reference method, and a report is generated including a conclusion about whether the evaluation methods or devices are clinically equivalent to the reference method or device.

Abstract: A shieldable needle device is provided. The shieldable needle device includes a housing, a needle cannula, a tip guard and a flexibly resilient drive mechanism. The housing includes a first lateral extension and a second lateral extension which are interconnected at a rearward end to form a hub portion from which the needle cannula extends. The tip guard telescopes over the needle cannula from a retracted position to an extended position. The drive mechanism is attached to the tip guard and is bent or coiled within the housing between the first and second lateral extension and retained in the bent or coiled position. Upon release of the drive mechanism, the tip guard is moved from a retracted position to an extended position, thereby protectively surrounding a tip of the needle cannula.

Abstract: A needle assembly that is adapted for blunting of both an intravenous puncture tip and a non-patient puncture tip is provided. The needle assembly includes a hub having an opening, an intravenous puncture tip, a non-patient puncture tip, a first blunting tip in concentric relation with the intravenous puncture tip, and a second blunting tip in concentric relation with the non-patient puncture tip. An actuator extends through the opening and is in engagement with either the first and second blunting tips or the intravenous puncture tip and the non-patient puncture tip. Activation of the actuator causes blunting of the intravenous puncture tip and the non-patient puncture tip by the first and second blunting tips. The needle assembly is particularly useful in connection with a blood collection system.

Abstract: A retractable safety needle assembly is provided. The needle assembly includes a tubular outer body, a retraction assembly contained with the outer body and a biasing element for applying a retraction force therebetween. The retraction assembly includes a cannula having an intravenous puncture tip and a non-patient puncture tip at opposing ends. In a first position, the intravenous puncture tip extends from a first end of the tubular outer body. The retraction assembly is adapted for movement within the tubular outer body from the first position to a second position in which the intravenous puncture tip and the non-patient puncture tip are contained entirely within the tubular outer body and are offset from a general axis defining the outer body.

Abstract: A device and method is provided for separating heavier and lighter fractions of a fluid sample. The device includes a plurality of constituents comprising a container and a composite element in the container. The composite element is a separator comprising at least two components and more particularly an elastic portion and a plug member. A fluid sample is delivered to the container and the device is subjected to centrifugation whereby the centrifugal load causes the elastic portion of the separator to deform so that the separator migrates into the fluid sample and stabilizes between the heavier and lighter fractions of the fluid sample. The elastic portion of the separator will resiliently return to its initial configuration upon termination of the centrifugal load such that the elastic portion sealingly engages the container and separates the heavier and lighter fractions of the fluid sample.

Abstract: A shieldable needle device including a needle cannula, a hub, a pair of wings extending laterally from opposing sides of the hub, a tip guard axially movable along the needle cannula from a proximal position substantially adjacent the hub to a distal position, and a drive member is disclosed. The drive member includes a first end connected to the hub and a second end connected to the tip guard and is extendable between a folded biased position and an extended position for moving the tip guard from the proximal position to the distal position. The pair of wings, when in a dorsal position, retain the drive member in the folded biased position maintaining the tip guard in a proximal position. Upon release of the wings, the drive member unfolds, extending the tip guard from the proximal position toward the distal position.

Abstract: A pivotable shielding needle device for shielding used needle cannulas. The device generally includes a hub with a needle, and a shield pivotable between a first position exposing the needle and a second position encompassing the needle. A biasing element acts on the shield to pivotally bias it toward the second position, with the shield maintained in the first position through a latch mechanism extending between the shield and the hub. A release arrangement extends from the hub and is squeezable to cause movement of a movable member which releases the latch mechanism, thereby causing the shield to be pivotally biased to the shielding position. Accordingly, activation and shielding of the needle can be effectively accomplished during removal of the needle device from a patient, thereby providing for passive activation of the device during normal use.

Abstract: A safety needle assembly has a needle hub and a needle cannula projecting from the hub. Wings project transversely from the hub to facilitate manipulation and positioning of the needle assembly. A shield is hingedly attached to the needle hub and can be rotated from a first position where the needle cannula is exposed to a second position where the needle cannula is shielded. At least one latch may be disposed on the shield for secure locked engagement with the hub, the wings and/or the tubing extending from the hub. A spring may also be provided for propelling the shield into the second position.

Abstract: The present invention is directed to a shieldable blood collection set as well as a needle assembly for use therein. The needle assembly includes a needle cannula having a puncture tip at a distal end thereof and a hub which supports the needle cannula. A hollow outer shield co-axially surrounds a distal end of the hub and has an inner surface which is in cooperating engagement with an outer surface of the hub. The hub includes a first tab extending outwardly at a position which is exposed from the outer shield, and the outer shield includes a second tab. The first tab and the second tab are configured such that opposing forces applied against the tabs cause the outer shield to move from a retracted position in which the puncture tip of the needle cannula is exposed, to an extended position in which the outer shield covers the puncture tip.

Abstract: The present invention is a syringe tip cap comprising a bottom portion, a top portion, an annular skirt extending therebetween and a plug that projects proximally from the bottom portion so as to be telescoped into the passage of a syringe tip. The plug provides means to allow air to be vented from the syringe with contacting the user. The syringe tip cap of the present invention also provides the user with an indication by tactile and visual feedback that the syringe has been vented.