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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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Nihon Kohden - 00843685100166

Nihon Kohden NKV-440 Ventilator System with SpO2/CO2
NIHON KOHDEN ORANGEMED, INC.
NKV-440
In Commercial Distribution

  • 00843685100166 ()


  • Neonatal/adult intensive-care ventilator

Nihon Kohden - 00843685100159

Nihon Kohden NKV-440 Ventilator System
NIHON KOHDEN ORANGEMED, INC.
NKV-440
In Commercial Distribution

  • 00843685100159 ()


  • Neonatal/adult intensive-care ventilator

Nihon Kohden - 00843685100135

The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 ventilator. The exhalation port provides a fixed leak and connection for pressure measurement.
NIHON KOHDEN ORANGEMED, INC.
EXH3301P
In Commercial Distribution

  • 00843685100135 ()
  • 10843685100132 ()
EXH3301P

  • Ventilator breathing circuit, single-use

Nihon Kohden - 00843685100074

The NPPV cap-ONE Mask Set (Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
NIHON KOHDEN ORANGEMED, INC.
MSK3315P
In Commercial Distribution

  • 20843685100078 ()
  • 00843685100074 ()
  • 10843685100071 ()
MSK3315P

  • CPAP/BPAP face mask, single-use

Nihon Kohden - 00843685100067

The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
NIHON KOHDEN ORANGEMED, INC.
MSK3314P
In Commercial Distribution

  • 10843685100064 ()
  • 00843685100067 ()
  • 20843685100061 ()
MSK3314P

  • CPAP/BPAP face mask, single-use

Nihon Kohden - 00843685100050

The NPPV cap-ONE Mask Set (Large) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
NIHON KOHDEN ORANGEMED, INC.
MSK3313P
In Commercial Distribution

  • 10843685100057 ()
  • 00843685100050 ()
  • 20843685100054 ()
MSK3313P

  • CPAP/BPAP face mask, single-use

Nihon Kohden - 00843685100043

The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediatric patients who are breathing spontaneously and require a tidal volume of 100mL or more with an oxygen concentration of 21 to 100%. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.
NIHON KOHDEN ORANGEMED, INC.
NKV-330
In Commercial Distribution

  • 00843685100043 ()
NKV-330

  • Portable electric ventilator

Nihon Kohden - 00843685100036

The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface.
NIHON KOHDEN ORANGEMED, INC.
DSP5500A
In Commercial Distribution

  • 00843685100036 ()
DSP5500A

  • Neonatal/adult intensive-care ventilator

Nihon Kohden - 00843685100029

The Nihon Kohden NKV-550-N is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through pediatric patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
NIHON KOHDEN ORANGEMED, INC.
NKV-550-N
In Commercial Distribution

  • 00843685100029 ()
NKV-550-N

  • Neonatal/adult intensive-care ventilator

Nihon Kohden - 00843685100012

The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
NIHON KOHDEN ORANGEMED, INC.
NKV-550-U
In Commercial Distribution

  • 00843685100012 ()
NKV-550-U

  • Neonatal/adult intensive-care ventilator

Nihon Kohden - 00843685100005

The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
NIHON KOHDEN ORANGEMED, INC.
NKV-550-S
In Commercial Distribution

  • 00843685100005 ()
NKV-550-S

  • Neonatal/adult intensive-care ventilator

Collimator ML01 II - 04056869011554

No Description
Siemens Healthcare GmbH
10092611
In Commercial Distribution

  • 04056869011554 ()


  • Manual-aperture-control diagnostic x-ray system collimator, motorized

Table RAD DST - 04056869009889

No Description
Siemens Healthcare GmbH
10273252
In Commercial Distribution

  • 04056869009889 ()


  • Basic diagnostic x-ray system table, powered

Table Rad CM - 04056869009872

No Description
Siemens Healthcare GmbH
10273220
In Commercial Distribution

  • 04056869009872 ()


  • Basic diagnostic x-ray system table, powered

Table RAD CS - 04056869009865

No Description
Siemens Healthcare GmbH
10273205
In Commercial Distribution

  • 04056869009865 ()


  • Basic diagnostic x-ray system table, powered

Z-touch Laser Registration Pointer - 04056481145514

The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration without fiducials.
Brainlab AG
18370-10A
In Commercial Distribution

  • 04056481145514 ()


  • Electromagnetic/optical surgical navigation device tracking system

EM Short Pointer - 04056481140410

No Description
Brainlab AG
18099-27
In Commercial Distribution

  • 04056481140410 ()
18099-27

  • Electromagnetic/optical surgical navigation device tracking system

EM Pointer - 04056481004927

No Description
Brainlab AG
18099-02C
In Commercial Distribution

  • 04056481004927 ()
18099-02C

  • Electromagnetic/optical surgical navigation device tracking system

EM Instrument Tracker - 04056481004873

No Description
Brainlab AG
18099-05A
In Commercial Distribution

  • 04056481004873 ()
18099-05A

  • Electromagnetic surgical navigation device tracking system

EM Registration Pointer - 04056481004811

No Description
Brainlab AG
18099-23
In Commercial Distribution

  • 04056481004811 ()
18099-23

  • Electromagnetic/optical surgical navigation device tracking system

EM Patient Reference - 04056481004804

No Description
Brainlab AG
18099-24
In Commercial Distribution

  • 04056481004804 ()
18099-24

  • Electromagnetic surgical navigation device tracking system

Softouch Pointer (Rev3) - 04056481004781

No Description
Brainlab AG
18390-10A
In Commercial Distribution

  • 04056481004781 ()
18390-10A

  • Robotic surgical navigation system

TPS - 04546540983930

XL Oscilliating Saw
STRYKER CORPORATION
5100131000
In Commercial Distribution

  • 04546540983930 ()
5100-131-000

  • Bone/joint surgical power tool motor, electric

TPS - 04546540977748

Micro Oscillating Saw
STRYKER CORPORATION
5100031000
In Commercial Distribution

  • 04546540977748 ()
5100-031-000

  • Bone/joint surgical power tool motor, electric

TPS - 04546540971272

Footswitch
STRYKER CORPORATION
5100008000
In Commercial Distribution

  • 04546540971272 ()
5100-008-000

  • Foot-switch, electrical

InSeca ARC Stylus - 08886479300023

The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable.
Aerin Medical Inc.
FG256
In Commercial Distribution

  • 08886479300023 ()
CAT409

  • Electrosurgical system

CastVac - 04546540923202

with Mobile Stand 220-240 V
STRYKER CORPORATION
0996000000
Not in Commercial Distribution

  • 04546540923202 ()
0996-000-000

  • Cast cutter vacuum system

NA - 04546540922182

Cast Cutter 230 V
STRYKER CORPORATION
0941000000
Not in Commercial Distribution

  • 04546540922182 ()
0941-000-000

  • Cast cutter, electrically-powered

Neptune - 04546540916389

Rover 3V
STRYKER CORPORATION
0700007000
Not in Commercial Distribution

  • 04546540916389 ()
0700-007-000

  • Surgical fluid/smoke waste management system

Neptune - 04546540916044

Docking Station with Detergent Dispenser 120 V~ 50-60Hz 3A
STRYKER CORPORATION
0700005000
Not in Commercial Distribution

  • 04546540916044 ()
0700-005-000

  • Surgical fluid/smoke waste management system disposal unit

NA - 04546540905451

Percutaneous Discectomy Probe
STRYKER CORPORATION
0407280000
In Commercial Distribution

  • 04546540905451 ()

  • Needle Gauge: 19.0 Gauge
  • Length: 6.0 Inch
0407280000

  • Diskectomy system, percutaneous, automatic

NA - 04546540905321

Percutaneous Discectomy Probe
STRYKER CORPORATION
0407260000
In Commercial Distribution

  • 04546540905321 ()

  • Needle Gauge: 17.0 Gauge
  • Length: 9.0 Inch
0407260000

  • Diskectomy system, percutaneous, automatic

CBCII ConstaVac - 04546540867698

Blood Conservation Kit PVC
STRYKER CORPORATION
0225426000
Not in Commercial Distribution

  • 34546540867699 ()
  • 04546540867698 ()

  • Diameter: 4.8 Millimeter
0225-426-000

  • Whole-blood-recovery autotransfusion system, manual

CBCII ConstaVac - 04546540867667

Blood Conservation Kit PVC
STRYKER CORPORATION
0225416000
Not in Commercial Distribution

  • 34546540867668 ()
  • 04546540867667 ()

  • Diameter: 6.4 Millimeter
0225-416-000

  • Whole-blood-recovery autotransfusion system, manual

CBCII Consta Vac - 04546540867605

Blood Conservation Kit PVC
STRYKER CORPORATION
0225414000
Not in Commercial Distribution

  • 34546540867606 ()
  • 04546540867605 ()

  • Diameter: 3.2 Millimeter
0225-414-000

  • Whole-blood-recovery autotransfusion system, manual

CBCII ConstaVac - 04546540867551

Blood Conservation System with Quick Disconnect and PVC Drain
STRYKER CORPORATION
0225028926
Not in Commercial Distribution

  • 34546540867552 ()
  • 04546540867551 ()

  • Diameter: 4.8 Millimeter
0225-028-926

  • Whole-blood-recovery autotransfusion system, manual

CBCII ConstaVac - 04546540867520

Blood Conservation System with Quick Disconnect and PVC Drain
STRYKER CORPORATION
0225028916
Not in Commercial Distribution

  • 34546540867521 ()
  • 04546540867520 ()

  • Diameter: 6.4 Millimeter
0225-028-916

  • Whole-blood-recovery autotransfusion system, manual

CBCII ConstaVac - 04546540867506

Blood Conservation System with Quick Disconnect and PVC Drain
STRYKER CORPORATION
0225028914
Not in Commercial Distribution

  • 34546540867507 ()
  • 04546540867506 ()

  • Diameter: 3.2 Millimeter
0225-028-914

  • Whole-blood-recovery autotransfusion system, manual

InterPulse - 04546540862204

Handpiece Set with Suction Tubing
STRYKER CORPORATION
0210900000
In Commercial Distribution

  • 34546540862205 ()
  • 04546540862204 ()
0210900000

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540862051

Handpiece Set with Coaxial Fan Spray Tip
STRYKER CORPORATION
0210218100
In Commercial Distribution

  • 34546540862052 ()
  • 04546540862051 ()
0210218100

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861955

Handpiece Set with Bone Cleaning Tip
STRYKER CORPORATION
0210210000E
In Commercial Distribution

  • 34546540861956 ()
  • 04546540861955 ()
0210210000E

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861870

with High Flow Tip and Dual-Spike Adaptor
STRYKER CORPORATION
0210167000
In Commercial Distribution

  • 34546540861871 ()
  • 04546540861870 ()
0210-167-000

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861856

with Suction, High Flow Tip and Dual-Spike Adaptor
STRYKER CORPORATION
0210166000
In Commercial Distribution

  • 34546540861857 ()
  • 04546540861856 ()
0210-166-000

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861832

with Suction and Dual-Spike Adaptor
STRYKER CORPORATION
0210165000
In Commercial Distribution

  • 34546540861833 ()
  • 04546540861832 ()
0210165000

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861818

Handpiece Set with Retractable Coaxial Fan Spray Tip and Suction Tube
STRYKER CORPORATION
0210118200
In Commercial Distribution

  • 34546540861819 ()
  • 04546540861818 ()
0210118200

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861795

Handpiece Set with Coaxial Fan Spray Tip and Suction Tube
STRYKER CORPORATION
0210118100
In Commercial Distribution

  • 34546540861796 ()
  • 04546540861795 ()
0210-118-100

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861764

Handpiece Set with Coaxial High Flow Tip and Suction Tube
STRYKER CORPORATION
0210114100
In Commercial Distribution

  • 34546540861765 ()
  • 04546540861764 ()
0210-114-100

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861740

Handpiece Set with High Flow Tip and Suction Tube
STRYKER CORPORATION
0210114000E
In Commercial Distribution

  • 34546540861741 ()
  • 04546540861740 ()
0210114000E

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861696

Handpiece Set with Soft Tissue Tip and Suction Tube
STRYKER CORPORATION
0210112000E
In Commercial Distribution

  • 34546540861697 ()
  • 04546540861696 ()
0210112000E

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540861641

Handpiece Set with Coaxial Bone Cleaning Tip and Suction Tube
STRYKER CORPORATION
0210110100
In Commercial Distribution

  • 34546540861642 ()
  • 04546540861641 ()
0210-110-100

  • Disposable surgical irrigation/aspiration system
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