Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A retractable needle assembly includes a housing having a sidewall defining a hollow bore, and an elongate plunger, the distal end of the plunger forming a reservoir within the hollow bore for containing a fluid therein. The plunger is adapted for slideable movement within the hollow bore. The assembly includes a hub disposed within the hollow bore and at least partially supporting a cannula therewith, and a needle retraction member engaged with the hub for manually selectable advancement with respect to a portion of the housing. The needle retraction member may be advanced from an initial position in which at least a portion of the needle is disposed outside the housing, to a retracted position in which the needle is fully surrounded by the housing. The elongate plunger may be advanced about the hub for extracting the fluid into the reservoir or expelling the fluid from the reservoir.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A specimen collection assembly including a flow control member for adjustably altering a flow path is disclosed. In one configuration, the flow control member defines a regulation channel in fluid communication with a lumen of a cannula, wherein the flow control member is configured to adjustably alter an effective flow distance between the lumen of the cannula and an interior of an evacuated collection container. In another configuration, the flow control member is positioned to vary an effective cross-sectional area of at least one of an inlet port and an outlet port adapted to be in fluid communication with the lumen and the evacuated collection container.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A closure for use with a specimen collection container is disclosed. The closure includes a base portion having a first end adapted for engagement with an open end of the specimen collection container, and a second end adapted for receiving a portion of a syringe assembly therein. The closure also includes a luer fitting connected to the base portion and having at least one channel for venting an interior of the specimen collection container to atmosphere during introduction of a fluid specimen from the syringe assembly into the specimen collection container. The closure further includes a shielding portion connected to the base portion and adapted to transition from an open position in which fluid communication is established between the first end and the second end through the luer fitting, to a closed position in which the luer fitting is fully shielded by the shielding portion.

Abstract: A method for detecting the presence of a microorganism in a fluid sample is disclosed. The method includes providing a fluid specimen within a specimen collection container having a sidewall defining an interior therein. The interior includes a mechanical separator adapted for separating the fluid sample into first and second phases within the specimen collection container and a sensing element capable of detecting the presence of a microorganism disposed therein. The method includes subjecting the specimen collection container to applied rotational force to isolate a concentrated microorganism region. The method also includes detecting by a sensing element the presence or absence of a microorganism within the concentrated microorganism region.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A closure for protectively sealing a biological fluid collection device is disclosed. The closure includes a cap and an adapter or connector. The closure of the present disclosure allows for connection to multiple different blood collection devices. In a first configuration, with the cap connected to the adapter, the closure may be connected to a first blood collection device. In a second configuration, with the cap disconnected from the adapter, the closure may be connected to a second blood collection device. An advantage of the closure of the present disclosure is that it enables a single closure device to accommodate a variety of connection options, hi one embodiment, the closure includes a barrier in communication with a portion of the cap, and the barrier protectively shields a portion of the stopper and/or protectively shields a portion of the cap.

Abstract: A biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications is disclosed.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A regulator for in-line modulation of the flow rate of fluid during blood collection includes a fluid transfer device for transferring fluid from a patient to a collection device. The fluid transfer device comprises a fluid passageway defined by a tubular sidewall and a flexible member associated with a portion of the tubular sidewall. The flexible member is configured for movement with respect to the fluid passageway upon exposure of the fluid transfer device to a differential pressure during a blood collection procedure to prevent collapse of a patients blood vessel. The flexible member of the regulator can be a frame surrounding a flexible diaphragm. Alternatively, the flexible member can include a flexible material integrally formed within the tubular sidewall of the pressure regulator.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A specimen collection assembly including a flow control member for adjustably altering a flow path is disclosed. In one configuration, the flow control member defines a regulation channel in fluid communication with a lumen of a cannula, wherein the flow control member is configured to adjustably alter an effective flow distance between the lumen of the cannula and an interior of an evacuated collection container. In another configuration, the flow control member is positioned to vary an effective cross-sectional area of at least one of an inlet port and an outlet port adapted to be in fluid communication with the lumen and the evacuated collection container.

Abstract: A specimen collection assembly (100) including a flow control member (106) for adjustably altering a flow path is disclosed. In one configuration, the flow control member (106) defines a regulation channel (166) in fluid communication with a lumen of a cannula (112), wherein the flow control member (106) is configured to adjustably alter an effective flow distance between the lumen of the cannula (112) and an interior of an evacuated collection container. In another configuration, the flow control member (106) is positioned to vary an effective cross-sectional area of at least one of an inlet port (346) and an outlet port (350) adapted to be in fluid communication with the lumen and the evacuated collection container.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A biological sample containment system that includes a biological specimen collection container for collecting a biological sample and a label for the container is disclosed. In one embodiment, the label includes a first or front side and a second or rear side having a readable information portion. The label is affixable to the container by the second side and with the label affixed to the container, the readable information portion on the second side is readable through a portion of the container. By including readable information on the second or rear side of the label, the amount of readable information that can be included on the label is increased by using the previously unused rear side of the label.