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510(k) Data Aggregation
K Number
K243392Device Name
Infusomat® Space Volumetric Infusion Pump Administration Sets
Manufacturer
B. Braun Medical Inc
Date Cleared
2025-07-24
(266 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K240578Device Name
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
Manufacturer
B. Braun Medical Inc.
Date Cleared
2024-07-31
(152 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241845Device Name
Introcan Safety® 2 IV Catheter
Manufacturer
B. Braun Medical Inc.
Date Cleared
2024-07-26
(30 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241385Device Name
Omnifix Syringe NRFit
Manufacturer
B. Braun Medical Inc.
Date Cleared
2024-07-13
(59 days)
Product Code
QEH
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.
Device Description
B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
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K Number
K231242Device Name
Perifix FX Catheter; Contiplex FX Catheter
Manufacturer
B. Braun Medical Inc.
Date Cleared
2023-09-15
(137 days)
Product Code
BSO, CAZ
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.
The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
Device Description
The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.
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K Number
K223479Device Name
AQUAbase nX
Manufacturer
B. Braun Medical Inc.
Date Cleared
2023-08-16
(271 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals.
The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.
The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.
Device Description
The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and monitoring of all operating parameters at any time. Customized parameters make a high water vield possible, even under poor raw water conditions. Raw water consumption is based solely on the end user's permeate needs. The touchscreen makes it possible for the user to monitor all production parameters as well as design every system function, including disinfection mode, individually and reproducibly.
The AQUAbase nX works on the reverse osmosis principle. Reverse osmosis describes the process of pressure-operated cross-filtration. Water flows at high pressure tangentially over a semipermeable membrane. As is the case with normal filtration, the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance, while other components (dissolved and undissolved water contents) are held back to a greater or lesser extent and leave the filtration unit in the concentrate flow. This is a purely physical separation process in the molecular range which does not change the components being separated either chemically, biologically or thermally.
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K Number
K213664Device Name
B. Braun Introcan Safety 2 IV Catheter
Manufacturer
B. Braun Medical Inc.
Date Cleared
2022-02-11
(81 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 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 one directional septum, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device 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 300 psi with a luer lock connection only.
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K Number
K212842Device Name
Microvolume Luer Access Device
Manufacturer
B. Braun Medical Inc.
Date Cleared
2022-01-18
(133 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microvolume Luer Access Device is a valve intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.
Device Description
The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.
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K Number
K202618Device Name
IV Administration Sets
Manufacturer
B. Braun Medical Inc.
Date Cleared
2021-09-24
(379 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IV 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. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. 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, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.
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K Number
K201469Device Name
Mini Spike Plus 6/8R
Manufacturer
B. Braun Medical Inc.
Date Cleared
2020-12-09
(189 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
B. Braun Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An IV additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R).
Device Description
The Mini Spike Plus 6/8 R is an IV additive dispensing pin for aspiration from single-dose containers with the size 6R* or 8R*. It is intended for withdrawal and injection from/in vials. The Mini Spike Plus 6/8 R transfer device is used for the preparation of medications contained in vials with a 20 mm vial closure diameter and a 22mm vial body diameter. The device is for single use and to only be used with single use drug dose vials. The device is configured with a snap cap covering a luer lock female access, a grip plate which features an integrated air filter (0.45 um) and a standard plastic piercing spike. The device provides two separate internal channels: One for injection and withdrawal of fluids, One for the pressure equalization between the vial and the environment. When the device's spike is pierced into a rubber stopper of a drug vial, these channels enable a fluid transfer between a syringe (that is connected with the device's luer connector on the top) and the vial. The vial adapter enables a permanent connection between the Mini Spike Plus 6/8 R and the vial. During the pressure equalization process there is an air exchange with the environment. In order to prevent any contamination of drugs being stored in the vials the air passes a 0.45um bacteria retentive air filter.
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