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aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney. The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney. The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components. Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.

aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2. Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder. The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 5 Cysto HD shall be disposed of as infected medical device with electronic components. Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design. The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables. The Ambu® aBox™ 2 has the following physical and performance characteristics: - Can process and display live imaging data from Ambu® aScope™ 5 Cysto HD to a monitor - Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD - Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

Ambu® aScope™ 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® aScope™ 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi. Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance. The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual quidance to and in the upper urinary tract. The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage of endoscopic instillation/ suction of fluids. The Ambu° aScope™ 5 Uretero is intended to be used with a compatible Ambu displaying unit, Ambu° aView™ 2 Advance. The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8″ LCD screen. The displaying unit is powered by a rechargeable lithium-ion battery and includes a power supply with region-specific power cable. The Ambu® aView™ 2 Advance has the following physical and performance characteristics: - · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor - · Can record, store and transport image data from Ambu® aScope™ 5 Uretero - Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aBox™ 2. The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual guidance to and in the upper urinary tract. The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2. The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables. The Ambu® aBox™ 2 has the following physical and performance characteristics: - · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor - · Can record, store and transport image data from Ambu® aScope™ 5 Uretero - Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum. The aBox ™2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2. The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum. The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work. The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables. The Ambu® aBox™ 2 has the following physical and performance characteristics: - · Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor - · Can record, store and transport image data from Ambu® aScope™ Duodeno 2 - Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

Ambu® aScope™ Gastro Large: The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Gastro Large Endoscopy System is a system used for endoscopic procedures in the upper gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2.

aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho System is a combination of an endoscope, Ambu® a5cope™ 5 Broncho, and a compatible displaying unit, Ambu® aView™ 2 Advance. Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor. The Ambu® aView™ 2 Advance, also referred to as a displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter. Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics: - · Displays the image from the Ambu® aScope™ 5 Broncho endoscope on the screen. - · Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope. - · Can connect to an external monitor. - · Reusable device.

Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

The Ambu® aScope™ 5 Broncho Sampler Set consists of: - Ambu® aScope™ 5 Broncho endoscope . - Two Sample Containers (Ambu® aScope BronchoSampler™ 60 SC) - Suction Connection Tube (SCT) - Bronchoscope Attachment Part (BAP) - 2 Luer lock adapters (Introducers) . Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428). The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC. The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60. BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure. The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored. The Suction Connection Tube (SCT) facilitates connection to suction tubing. The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set. Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics: - Maneuverable Ambu® aScope™ 5 Broncho endoscope tip controlled by the user - Flexible Ambu® aScope™ 5 Broncho endoscope insertion cord - Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope - Sterilized by Ethylene Oxide - For single use - Enables aspiration and sample collection in BAL and BW procedures

Ambu® aScope™ Colon: The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy. The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment. Ambu® aBox™ 2: The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Colon Endoscopy System is a system used for endoscopic procedures in the gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Colon, and a displaying unit, the Ambu® aBox™ 2. The Ambu® aScope™ Colon is a sterile, single-use flexible colonoscope for accessing and examining the lower gastrointestinal anatomy. The endoscope provides a working channel for use of endotherapy accessories, as well as insufflation suction, rinsing and a water jet function. Visualization is realised via an integrated camera module with bulit-in LEDs for illumination. The Ambu® aBox™ 2 displaying unit has the following physical and performance characteristics: Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device