Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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System base using a 220V-240V, 7A (circuit breaker), 50/60 Hz (10A power source required) power source
Terumo Cardiovascular Systems Corporation
801764
In Commercial Distribution

  • 00886799000663 ()
801764

  • Cardiopulmonary bypass system, roller type
System base using a 100V-120V, 15A (circuit breaker), 50/60 Hz (20A power source required) power source
Terumo Cardiovascular Systems Corporation
801763
In Commercial Distribution

  • 00886799000656 ()
801763

  • Cardiopulmonary bypass system, roller type
The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
801188
In Commercial Distribution

  • 00886799000588 ()
801188

  • Cardiopulmonary bypass system gas control unit
The centrifugal control unit provides the local display and control mechanism for the centrifugal pump and serves as the interface between the centrifugal motor and the rest of the heart-lung system.
Terumo Cardiovascular Systems Corporation
801046
In Commercial Distribution

  • 00886799000557 ()
801046

  • Cardiopulmonary bypass system centrifugal pump drive unit
Roller Pump (6" Blue). The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
801041
In Commercial Distribution

  • 00886799000540 ()
801041

  • Cardiopulmonary bypass system roller pump
Roller Pump (4" Blue). The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
801040
In Commercial Distribution

  • 00886799000533 ()
801040

  • Cardiopulmonary bypass system roller pump
Roller pump hand cranks used to rotate the roller pump occlusion mechanism during an electrical power failure. These hand cranks can be used on either the large 6" or the small 4" roller pumps.
Terumo Cardiovascular Systems Corporation
801016
In Commercial Distribution

  • 00886799000526 ()
801016

  • Cardiopulmonary bypass system, roller type
Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Terumo Cardiovascular Systems Corporation
217390
In Commercial Distribution

  • 00886799000519 ()
217390

  • Cardiopulmonary bypass system air bubble/fluid level detector
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 3/8"x3/32" sensor.
Terumo Cardiovascular Systems Corporation
201380
In Commercial Distribution

  • 00886799000502 ()
201380

  • Cardiopulmonary bypass system air bubble/fluid level detector
The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and detects the presence or absence of blood or prime solution at the point of detection. Red.
Terumo Cardiovascular Systems Corporation
195274
In Commercial Distribution

  • 00886799000496 ()
195274

  • Cardiopulmonary bypass system air bubble/fluid level detector
The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and detects the presence or absence of blood or prime solution at the point of detection. Yellow.
Terumo Cardiovascular Systems Corporation
195215
In Commercial Distribution

  • 00886799000489 ()
195215

  • Cardiopulmonary bypass system air bubble/fluid level detector
Ultrasonic couplant used to facilitate the transmission of sound energy between the flow sensor and extracorporeal tubing.
Terumo Cardiovascular Systems Corporation
164278
In Commercial Distribution

  • 00886799000472 ()
164278

  • Cardiopulmonary bypass system centrifugal pump drive unit
Manual drive motor used to rotate the disposable centrifugal pump in the event of electrical power loss.
Terumo Cardiovascular Systems Corporation
164268
In Commercial Distribution

  • 00886799000465 ()
164268

  • Cardiopulmonary bypass system centrifugal pump drive unit
The centrifugal motor is the drive mechanism necessary to pump fluid through a disposable centrifugal pump which is magnetically coupled to the motor.
Terumo Cardiovascular Systems Corporation
164267
In Commercial Distribution

  • 00886799000458 ()
164267

  • Cardiopulmonary bypass system centrifugal pump drive unit
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 3/8"x3/32" sensor.
Terumo Cardiovascular Systems Corporation
149673
In Commercial Distribution

  • 00886799000366 ()
149673

  • Cardiopulmonary bypass system air bubble/fluid level detector
8000 Perfusion System Arterial Monitor Providing Temperature and Pressure Measurement Display.
Terumo Cardiovascular Systems Corporation
16413
In Commercial Distribution

  • 00886799000205 ()
16413

  • Cardiopulmonary bypass system temperature control unit
  • Cardiopulmonary bypass system pressure monitor
Base, for Sarns™ Modular Perfusion System 8000
Terumo Cardiovascular Systems Corporation
16401
In Commercial Distribution

  • 00886799000175 ()
16401

  • Cardiopulmonary bypass system, roller type
The flow sensor is a non-invasive ultrasonic transducer used to measure fluid flow. Includes ultrasonic coupling gel.
Terumo Cardiovascular Systems Corporation
6382
In Commercial Distribution

  • 00886799000083 ()
6382

  • Cardiopulmonary bypass system centrifugal pump drive unit
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 1/4"x3/32" sensor. Includes cable and holder.
Terumo Cardiovascular Systems Corporation
5791
In Commercial Distribution

  • 00886799000052 ()
5791

  • Cardiopulmonary bypass system air bubble/fluid level detector
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 1/4"x1/16" sensor. Includes cable and holder.
Terumo Cardiovascular Systems Corporation
5785
In Commercial Distribution

  • 00886799000045 ()
5785

  • Cardiopulmonary bypass system air bubble/fluid level detector
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 3/8"x3/32" sensor. Includes cable and holder.
Terumo Cardiovascular Systems Corporation
5773
In Commercial Distribution

  • 00886799000038 ()
5773

  • Cardiopulmonary bypass system air bubble/fluid level detector
No Description
LivaNova Deutschland GmbH
Pads Green
In Commercial Distribution

  • 34033817900635 ()
  • 04033817900634 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Pads White
In Commercial Distribution

  • 34033817900628 ()
  • 04033817900627 ()


  • Cardiopulmonary bypass system, roller type
No Description
Maquet Cardiopulmonary AG
Extended Mast System
In Commercial Distribution

  • 04037691762326 ()
701043271

  • Cardiopulmonary bypass system, roller type
CARDIOHELP Holder for mast
Maquet Cardiopulmonary AG
CARDIOHELP Holder for mast HKH 9102-M
In Commercial Distribution

  • 04037691720791 ()
70104.9584

  • Medical device rail
Gas bottle holder for helicopter.
Maquet Cardiopulmonary AG
Gas bottle holder f. helicopter HKH 8880
Not in Commercial Distribution

  • 04037691718330 ()
70105.0901

  • Medical device rail
CARDIOHELP-i mobile holder. The CARDIOHELP-i Mobile Holder is for connection to the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP mobile holder CARDIOHELP protection cover
Maquet Cardiopulmonary AG
Cardiohelp Mobile Holder HKH 8860
Not in Commercial Distribution

  • 04037691717968 ()
70105.0897

  • Medical device rail
Level Sensor Pads LSP 20-531, non-sterile, box of 100 pieces
Maquet Cardiopulmonary AG
LSP 20-531
In Commercial Distribution

  • 04037691687308 ()
701022208

  • Cardiopulmonary bypass system, roller type
The CLS is a device to monitor blood or saline level in a reservoir and to generate an electrical signal if the level falls below a predetermined value.
Maquet Cardiopulmonary AG
CLS L2.0
In Commercial Distribution

  • 04037691682907 ()
70104.9252

  • Cardiopulmonary bypass system air bubble/fluid level detector
No Description
Maquet Cardiopulmonary AG
Mast adapter D30 H45
In Commercial Distribution

  • 04037691682549 ()
701051531

  • Cardiopulmonary bypass system, roller type
CARDIOHELP Emergency Drive Holder for mast
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive Holder, Mast
In Commercial Distribution

  • 04037691645155 ()
70104.8006

  • Medical device rail
CARDIOHELP Emergency Drive Holder for rail
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive holder, Rail
In Commercial Distribution

  • 04037691645148 ()
70104.9304

  • Medical device rail
CARDIOHELP Emergency Drive
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive (w/o holder)
Not in Commercial Distribution

  • 04037691643526 ()
70104.8002

  • Cardiopulmonary bypass system, roller type
The Venous Probe is to measure SO2, Hb, HCT and venous temperature as an accessory for CARDIOHELP. The CARDIOHELP System is a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator.
Maquet Cardiopulmonary AG
Venous Probe
In Commercial Distribution

  • 04037691641041 ()

  • Weight: 0.208 Kilogram
  • Total Volume: 2.569 Liter
70104.8803

  • Extracorporeal blood gas/pH monitor
No Description
Maquet Cardiopulmonary AG
Side guard
In Commercial Distribution

  • 04037691585598 ()
701043272

  • Cardiopulmonary bypass system, roller type
The STI 1/2" x 1/16" (4 pcs) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.
Maquet Cardiopulmonary AG
STI 1/2" x 1/16" (4 pcs)
In Commercial Distribution

  • 04037691477251 ()

  • Weight: 0.16 Kilogram
701020800

  • Cardiopulmonary bypass system, roller type
The STI 1/4" x 1/16" (4 pcs.) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.
Maquet Cardiopulmonary AG
STI 1/4" x 1/16" (4 pcs)
In Commercial Distribution

  • 04037691477206 ()

  • Weight: 0.02 Kilogram
701020798

  • Cardiopulmonary bypass system, roller type
No Description
Maquet Cardiopulmonary AG
Complete Holder 200mm Arm
In Commercial Distribution

  • 04037691457659 ()
701045168

  • Cardiopulmonary bypass system, roller type
Wall holder for ambulance. Mandatory for ambulance transportation.
Maquet Cardiopulmonary AG
Wall holder HKH 8820
Not in Commercial Distribution

  • 04037691456584 ()
70104.5366

  • Medical device rail
CONSOLE R5100052 PERFORMER CPB,UNIV
MEDTRONIC, INC.
R5100052
In Commercial Distribution

  • 00885074514857 ()


  • Cardiopulmonary bypass system, roller type
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