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 ID00886799001325
NIH Device Record Keyb2534a3c-fddc-4a78-b491-f5f3088af4b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTerumo® Advanced Perfusion System 1
Version Model Number816300
Catalog Number816300
Company DUNS177655466
Company NameTerumo Cardiovascular Systems Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886799001325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

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

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

Trademark Results [Terumo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TERUMO
TERUMO
98436800 not registered Live/Pending
Terumo Kabushiki Kaisha
2024-03-06
TERUMO
TERUMO
97802240 not registered Live/Pending
Terumo Kabushiki Kaisha
2023-02-20
TERUMO
TERUMO
86490751 5590542 Live/Registered
Terumo Kabushiki Kaisha
2014-12-26
TERUMO
TERUMO
73297771 1276674 Dead/Cancelled
Terumo Kabushiki Kaisha (Termumo Corporation)
1981-02-19
TERUMO
TERUMO
72322168 0890553 Dead/Cancelled
KABUSHIKI KAISHA JINTAN TERUMO
1969-03-19

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