Search Results
Found 4 results
510(k) Data Aggregation
K Number
K152050Device Name
Pencylcap
Manufacturer
B. BRAUN MELSUNGEN AG
Date Cleared
2016-03-02
(223 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MELSUNGEN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pencylcap is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.
Device Description
Not Found
Ask a Question
K Number
K131040Device Name
EXTAVIPRO STERICAN 30G
Manufacturer
B. BRAUN MELSUNGEN AG
Date Cleared
2013-07-15
(91 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MELSUNGEN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ExtaviPro™ Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
Device Description
ExtaviPro™ Sterican™ 30G hypodermic needles are comprised of a steel cannula that is sharpened to a point at one end. The other end is bonded to a vellow color-coded female Luer Lock hub designed for attachment to a corresponding male connector, such as a syringe. A protective cap must be removed before injection.
Ask a Question
K Number
K111236Device Name
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
Manufacturer
B. BRAUN MELSUNGEN AG
Date Cleared
2011-08-30
(120 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MELSUNGEN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Introcan Safety® 3 Closed 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 and blood intravascularly.
The 18-22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi with a 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.
The Introcan Safety® 3 will be offered in the following gauge sizes and lengths:
18ga x 1-3/4" (45mm)
18ga x 1-1/4" (32 mm)
20ga x 1-1/4" (32mm)
20ga x 1" (25mm)
22ga x 1" (25mm)
24ga x ¾" (19mm)
Introcan Safety® 3 design is described as 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 platform is designed to improve catheter stability while minimizing catheter movement within the vessel.
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.
Ask a Question
K Number
K102033Device Name
COMBITRANS MONITORING SETS AND ACCESSORIES
Manufacturer
B. BRAUN MELSUNGEN AG
Date Cleared
2011-04-07
(262 days)
Product Code
DRS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MELSUNGEN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The B. Braun Combitrans Monitoring Sets are intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals.
The Combitrans flush device provides a continuous flush rate from approximately 3 ml/hr and allows a switch to approximately 300 ml/hr. When using the Combitrans device in neonates, infants or small children. A syringe pump should be used to control the flow rate, which should not exceed 3 ml/hr.
Device Description
The Combitrans Monitoring Set is a pre-calibrated blood pressure transducer designed to transform physiological pressure waveforms into electrical signals using a piezoresistive sensor. The set is supplied in 6 configurations:
1) Combitrans Monitoring Set, Venous (blue striped tubing).
2) Combitrans Monitoring Set, Arterial (red striped tubing).
3) Combitrans Monitoring Set, Pulmonary-Arterial (yellow striped tubing).
4) Exadyn Combitrans Monitoring Set (blue and red striped tubing with additional stopcock for the measurement of venous and arterial blood pressure with one transducer).
5) Combitrans Add-On Set (consists only of the transducer, flush device, three-way stopcock and pressure tubing for customized set design and extension.
6) Combitrans Fixation Tape (includes a hook and loop band/Velcro fixation tape used to fix the Combitrans transducer to the patient forearm or a stand).
Each set has the same basic intended use and transducer components, but varies according to the features indicated above. With each of the sets, a fluid (saline) filled pressure transmitting catheter can be connected to a venous, arterial or pulmonary-arterial patient catheter that is in indirect contact with the patient's bloodstream.
Each of the six Combitrans Monitoring Sets listed above are composed of the following components: a disposable extra-vascular blood pressure transducer, a sensor that converts hemodynamic pressure waveforms into electrical signals, a transducer cable which is connected to a pressure transmitting catheter system, a flush device and a three-way stopcock. The Combitrans transducer and the sensor function together such that physiologic waveforms are transmitted from a fluid filled cavity inside the transducer housing onto the sensor via a silicone gel cushion.
The Combitrans Monitoring Set finger-activated flush device provides a continuous flush from approximately 3 mL/hr and allows a switch to approximately 300 ml/hr. The Combitrans Monitoring Set interfaces with a standard infusion set and a transducer cable, which transmits electrical signals onto a monitor or into a computer for further processing, graphic presentation or storage. When using the Combitrans device in neonates, infants or small children, the standard gravity infusion set is not used but is exchanged for a syringe pump to control the flow rate. which should not exceed 3 ml/hr.
Combitrans disposable transducers, as well as catheters and infusion systems, are indirectly in contact with the blood stream. They are supplied sterile, individually packaged and for single use only.
Accessories available for use with the Combitrans Monitoring Sets include attachment plates for the attachment of the transducer to an infusion stand. A wide range of interface cables using different plug design and configurations are also available to facilitate storage or visualization of blood pressure measurements on patient monitors.
Ask a Question
Page 1 of 1