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510(k) Data Aggregation
K Number
K241586Device Name
PIVO Pro Needle-free Blood Collection Device
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Date Cleared
2025-02-27
(269 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.
Device Description
The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.
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K Number
K230865Device Name
PIVO Pro Needle-free Blood Collection Device
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Date Cleared
2023-09-28
(183 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
Device Description
The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular catheter (IV) system. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing, and winged clip on the distal end. The winged clip attaches to the IV system. The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV.
The device is available in three sizes: 20GA, 22GA, and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPort™ IV Access.
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K Number
K173354Device Name
BD Nexiva Diffusics Closed IV Catheter Systems
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Date Cleared
2017-12-15
(51 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Device Description
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device
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K Number
K161777Device Name
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Date Cleared
2016-08-29
(61 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Device Description
BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, vent plug and, with dual port configurations, a pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. For dual port configurations, a BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
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K Number
K151698Device Name
BD Angiocath IV Catheter, BD Insyte IV Catheter
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2015-07-27
(33 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Device Description
Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are made of BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made of FFP Polymer material
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K Number
K102520Device Name
BD NEXIVA CLOSED IV CATHETER SYSTEM
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2011-01-06
(126 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As indicated in 21 CFR Part 880.5200, The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Device Description
The BD Nexiva™ Closed IV Catheter System consists of an over-the needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needleshielding mechanism.
The design of the Nexiva™ IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NexivaTM device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection of a BD Q-Syte™ luer access port.
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K Number
K100775Device Name
BD INTIMA II CLOSED IV CATHETER
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2010-06-03
(77 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.
Device Description
The Intima II IV Catheter consists of a Vialon® material catheter, a notched needle to enhance flashback visualization, septum, extension tubing and either a straight or Y Luer connector. A needle-accessed PRN is attached to the Luer connector. An end cap is attached to the second Luer connector on the Y design. Blood is contained within the device. A slide clamp is provided on the extension tube. A notched needle resides within the catheter until it is withdrawn through the septum after the catheter has been threaded into the vein. The needle unit includes a paddle that is held during the insertion process. This device does not include a needle-shielding mechanism.
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K Number
K050207Device Name
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2005-04-07
(69 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Posiflow Positive Displacement Valve is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. The BD Positive Displacement Valve can be used by itself or as a component on an extension/infusion set, a vial adapter, or as a connector to convert a standard access site to a needleless access site.
Device Description
The BD Posiflow Positive Displacement Valve is a needleless alternative to an IV set injection port. It is accessed by a standard luer taper connection for continuous or intermittent infusion or withdrawal of fluids. The positive displacement feature is intended to eliminate fluid retrograde, which normally results when disconnecting a connector from an IV injection site.
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K Number
K042862Device Name
BD ONECATH
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2004-12-03
(49 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Device Description
The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.
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K Number
K032843Device Name
NEXIVA CLOSED IV CATHETER SYSTEM
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Date Cleared
2004-02-27
(169 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Device Description
The BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needle-shielding mechanism.
The design of the Nexiva IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port.
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