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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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CDI™ H/S Cuvette 1/2 x 1/2 - Japan - 00699753270114

No Description
Terumo Cardiovascular Systems Corporation
CV-6912
In Commercial Distribution

  • 50699753270119 ()
  • 30699753270115 ()
  • 00699753270114 ()


  • Cardiopulmonary bypass system blood gas sensor

Vyaire - 00819601021389

Description: 4% CO2, 16% O2, Bal. N2; Cylinder: ED; Valve: CGA 973; For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked; For Japan; Vyaire Part #: 763450
AIRGAS USA LLC
Pulmonary Function Cal Gas
In Commercial Distribution

  • 00819601021389 ()

  • Total Volume: 415 Liter
  • Pressure: 1650 Pound per Square Inch
Z03NI804EDC001

  • Pulmonary function analysis system, adult

Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne - 00849111075176

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
Zoll Circulation, Inc.
CL-2295
In Commercial Distribution

  • 00849111075176 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 9.3 French


  • Intravascular core temperature regulation system catheter

J&J DePuy Synthes convenience kit - 07612367080590

Convenience kit containing: 1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord 1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces) 1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China)
Medela AG
101043438
In Commercial Distribution

  • 07612367080590 ()
101043438

  • Surgical suction pump

ECG Electrodes - 20884838007783

Disposable radiolucent foam electrode for use with X-ray procedures. Silver/silver-chloride (Ag/AgCI)sensor, non-metallic snap, pre-gelled; Oval shape, 43mm x 36mm size; 30 per pack, 600 electrodes per case; Shelf life; at least 6 months; Can be used with all Philips Adult ECG Monitors. Only available in Japan
Philips Medical Systems Hsg
ADULT RADIOLUCENT ELECTRODE (FOAM)
In Commercial Distribution

  • 20884838007783 ()
  • 10884838007786 ()
989803148821

  • Electrocardiographic electrode, single-use

CONTOUR® PLUS BLUE - 00301937035029

"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China)"
ASCENSIA DIABETES CARE US INC.
7035
In Commercial Distribution

  • 40301937035027 ()
  • 00301937035029 ()
  • 00301937035012 ()
90006207

  • Glucose monitoring system IVD, home-use

CONTOUR® PLUS BLUE - 00301937035012

"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China) Contour Plus control solution (Product of USA)"
ASCENSIA DIABETES CARE US INC.
7035
Not in Commercial Distribution

  • 00301937035012 ()
  • 40301937035010 ()
90006207

  • Glucose monitoring system IVD, home-use

AUTO REF/KERATOMETER - 06971821402011

This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. RM-9000 Measuring fuction only has refractive measurement. RM-9000 Auto refractometer Adopts the ARM processor and image processing technology in China—faster system and clearer image Mature technique from Japan. Humanized auto mist test process: will reduce errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD color screen provides more comfortable interface Supports the data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure can give the customer a sense of beauty and comfortable operation.
Ningbo Ming Sing Optical R & D Co., Ltd.
RM-9000
In Commercial Distribution

  • 06971821402011 ()


  • Automated ophthalmic refractometer

AUTO REF/KERATOMETER - 06971821402004

This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. KR-9000 Auto ref/keratometer Has the functions of both refractometer and keratometer Adopts the latest ARM processor and image processing technology—fast system and more clear images Mature technique from Japan. Humanized auto mist test process: will reduce the errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD screen provides more comfortable interface Supports data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure give the customer sense of beauty and comfortable operation.
Ningbo Ming Sing Optical R & D Co., Ltd.
KR-9000
In Commercial Distribution

  • 06971821402004 ()


  • Automated ophthalmic refractometer

SB Knife /Standard type - 04545499064691

The SB Knife is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker’s diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knife is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators. The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan.
SB-KAWASUMI LABORATORIES, INC.
MD-47706
In Commercial Distribution

  • 24545499064695 ()
  • 04545499064691 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 1.8 Meter


  • Endoscopic electrosurgical electrode, monopolar, single-use
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