Terumo® Advanced Perfusion System 1 816300

GUDID 00886799001325

Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical User Interface (GUI) to provide a centralized display of system information and onscreen control of all system devices

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system, roller type

• Primary Device ID: 00886799001325
• NIH Device Record Key: b2534a3c-fddc-4a78-b491-f5f3088af4b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Terumo® Advanced Perfusion System 1
• Version Model Number: 816300
• Catalog Number: 816300
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886799001325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151349

FDA Product Code

• DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Terumo® Advanced Perfusion System 1]

• 00886799001479: Cable assembly, for use with the air bubble detection module and sensor
• 00886799001387: The centrifugal control unit provides the local display and control mechanism for the centrifuga
• 00886799001370: The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for a
• 00886799001363: The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for a
• 00886799001325: Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical Use
• 00886799000892: The flow sensor is a non-invasive ultrasonic transducer used to measure fluid velocity.
• 00886799000885: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799000878: The occluder head provides a computer-controlled tube occlusion mechanism. The occluder head is
• 00886799000847: Cable used to connect the data module to the intended device.
• 00886799000830: Cable used to connect the CDI data module to the intended CDI device.
• 00886799000809: A PC Card contained in one of the CCM card slots that stores a system activity log and is used b
• 00886799000793: The Configuration PC Card is used to backup System 1 Perfusion Configurations. These cards also
• 00886799000786: This kit is provided to store and house miscellaneous items: roller pump knob colored caps, wire
• 00886799000779: The occluder module serves as the interface between the occluder head and the system. The occlud
• 00886799000762: The Interface Module for CDI 500 Module provides the interface between the CDI™ 500 Blood Para
• 00886799000755: The Interface Module for CDI 100 provides the interface between a CDI ™ 100 or CDI™ 100 Satu
• 00886799000748: The interface between the temperature sensor and the rest of the system.
• 00886799000731: The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion s
• 00886799000724: The pressure module serves as the interface between up to two pressure transducers and the syste
• 00886799000717: The level detect module serves as the interface between the level sensor and the system. This mo
• 00886799000700: The Air Bubble Detect (ABD) module is the interface between an air sensor and the system. The AB
• 00886799000694: Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical Use
• 00886799000687: The flowmeter module provides the interface between the flow sensor and the system. The module p
• 00886799000663: System base using a 220V-240V, 7A (circuit breaker), 50/60 Hz (10A power source required) power
• 00886799000656: System base using a 100V-120V, 15A (circuit breaker), 50/60 Hz (20A power source required) power
• 00886799000649: The 15" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles
• 00886799000595: The 33" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles
• 00886799000588: The electronic gas blender is an optional module that integrates into the APS1 chassis. It accep
• 00886799000557: The centrifugal control unit provides the local display and control mechanism for the centrifuga
• 00886799000540: Roller Pump (6" Blue). The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway
• 00886799000533: Roller Pump (4" Blue). The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway
• 00886799000526: Roller pump hand cranks used to rotate the roller pump occlusion mechanism during an electrical
• 00886799000519: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor
• 00886799000502: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799000496: The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and
• 00886799000489: The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and
• 00886799000472: Ultrasonic couplant used to facilitate the transmission of sound energy between the flow sensor
• 00886799000465: Manual drive motor used to rotate the disposable centrifugal pump in the event of electrical po
• 00886799000458: The centrifugal motor is the drive mechanism necessary to pump fluid through a disposable centri
• 00886799000366: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799000083: The flow sensor is a non-invasive ultrasonic transducer used to measure fluid flow. Includes ult
• 00886799000052: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799000045: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799000038: The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion
• 00886799001394: The flexible mounting arm attaches to the APS1 vertically mounting pole and is used as a mount f
• 00886799001356: A bracket that mounts to a vertical pole that extends towards the floor to hold one pump lower
• 00886799001349: A bracket that mounts to a vertical pole that will hold two pumps
• 00886799000922: US hose kit, Oxygen and air hoses used for connecting medical gases to the gas blender.
• 00886799000632: A bracket that attaches to a vertical pole and is used as a mount for up to two flowmeter module
• 00886799000564: A bracket that mounts to a vertical pole that will hold one roller pump