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510(k) Data Aggregation
K Number
K220756Device Name
Introcan Safety 2 IV Catheter
Manufacturer
Date Cleared
2022-06-23
(100 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Introcan Salety® 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
Device Description
The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing. This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used intravascularly with power injectors for which the maximum pressure setting is 325 psi with a luer lock connection only.
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K Number
K220626Device Name
Introcan Safety IV Catheter
Manufacturer
Date Cleared
2022-05-14
(71 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
Device Description
The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.
The passive safety needle-shielding mechanism of the Introcan Safety® IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.
This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used with power injectors with a maximum pressure setting is 325 psi with a luer lock connection only.
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K Number
K213778Device Name
IV Administration Set
Manufacturer
Date Cleared
2022-03-03
(90 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Device Description
IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.
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K Number
K213085Device Name
Introcan Safety 3 Closed IV Catheter
Manufacturer
Date Cleared
2021-10-25
(31 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.
Device Description
The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism. Introcan Safety® 3 design is a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The Introcan Safety® 3 catheter has an integrated stabilization is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 3 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.
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K Number
K173361Device Name
IV Administration Set
Manufacturer
Date Cleared
2018-06-26
(243 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Device Description
IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.
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K Number
K172831Device Name
Perfusor® Space Syringe Infusion Pump System
Manufacturer
Date Cleared
2018-06-12
(267 days)
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
B.Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perfusor® Space Syringe Infusion Pump System is intended for use on adults, pediatrics and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes intra-arterial, subcutaneous, epidural and enteral.
The Perfusor® Space Syringe Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities and for medical ground and/or air transport situations.
Device Description
The Perfusor® Space Syringe Infusion Pump System includes an external, transportable, electronic infusion pump and pump accessories.
The Perfusor® Space Syringe Infusion Pump utilizes a swivel drive pumping mechanism and operates on a 12V DC power source that can be provided from a battery or through external sources such as a power supply connected to a 120V AC wall outlet.
The front panel of the Perfusor® Space Pump includes a backlit graphical display, a backlit keypad with 10 push buttons including directional arrows to navigate through menu items and indicator lamps to alert the clinician to critical conditions.
The Perfusor® Space Syringe Infusion Pump is capable of wireless communication both inbound and outbound. Autoprogramming of the pump is possible where the pump receives infusion parameters wirelessly from the electronic health record over the hospital Wireless Local Access Network.
The B. Braun Space Station is a flexible docking and communication system designed to accommodate multiple Perfusor® Space Syringe Infusion Pumps for use in a medical facility.
Space Com is a communication device that has been integrated into the SpaceCom supports different interfaces such as Ethernet, PS2-Keyboard, Serial, USB ports and WLAN network card. Data transfer with the pumps is provided via an internal CAN bus. The pumps are coupled together with connectors on the inner backside of the SpaceStation. These connectors provide the voltage supply, distribute the information in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending. Features like barcoding and wireless data transmission are enabled when a Perfusor® Space Pump is housed within a SpaceStation with Space Com. The outbound data communication through Space Com transfers status data of the infusion pumps to a hospital server.
Space OnlineSuite is a server based software system which provides the following applications:
Space Server Core is the basic server framework for Space application framework provides basic server functions like User Management, License Management, Communication Service, Security and Maintenance Functions. These functions are used by the administrator of the Space OnlineSuite. Drug Library Manager and Upload Manager applications also use the basic functions of SpaceServer Core.
Drug Library Manager is used to create and administer a drug library which can be used in the Perfusor® Space Syringe Infusion Pump. These features are designed to enhance medication safety and reduce medication errors.
Upload Manager can be used to manage the upload of drug libraries to any single B. Braun Space infusion pump, multiple Space pumps within a facility or to all Space pumps on the System. The drug libraries will be uploaded to SpaceCom (within SpaceStation) and then transferred via CAN bus (Controller Area Network) to the pumps or to a single Perfusor® Space Syringe Infusion Pump directly.
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