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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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No Description
BREG, INC.
BATTERY PACK, 4AA, PC KODIAK
In Commercial Distribution

  • 00672736020678 ()
97050

  • Primary battery
  • Inflatable hot/cold therapy pack/electric pump
Dynamic Mixing Tips to be used only with the Vacu-Mixer Automated Mixing Machine, 50/bag
HO DENTAL COMPANY LLC
Vacu-Mixer Tip
In Commercial Distribution

  • 00850211006229 ()
  • 00850211006458 ()


  • Dental material mixing nozzle
TIDIShield Slush/Warming Machine Covers Polyurethane Sterile 44in x 44in x 1in 24 per Case
TIDI PRODUCTS, LLC
531903
Not in Commercial Distribution

  • 01618125152420 ()


  • Urological fluid funnel, sterile
Ecg machine lead wire /MQ type/ten lead /4mm banana plug /AHA/ 1.2m + 0.8m /CSM
Unimed Medical Supplies, Inc.
LQ10-LB0
In Commercial Distribution

  • 06945664892155 ()


  • Electrocardiographic lead set, reusable
Ecg machine integrated cable /GLOBE/ ten guide/clamp /IEC/ 3.0m + 1.2m *4+ 0.8m *6/331
Unimed Medical Supplies, Inc.
E10R/30-GL-P/I
In Commercial Distribution

  • 06945664899567 ()


  • Electrocardiographic lead set, reusable
ECG machine integrated cable/Edan/ten lead/clamp/IEC/2.2M+1.2M*4+0.8M*6/331
Unimed Medical Supplies, Inc.
E10-ED-P/I
In Commercial Distribution

  • 06945664897860 ()


  • Electrocardiographic lead set, reusable
The occluder head provides a computer-controlled tube occlusion mechanism. The occluder head is controlled via signals received from the occluder module. The occulder head can be detached from the occluder module.
Terumo Cardiovascular Systems Corporation
806455
In Commercial Distribution

  • 00886799000878 ()
806455

  • Cardiopulmonary bypass system, roller type
Cable used to connect the data module to the intended device.
Terumo Cardiovascular Systems Corporation
804982
In Commercial Distribution

  • 00886799000847 ()
804982

  • Cardiopulmonary bypass system mounting unit
Cable used to connect the CDI data module to the intended CDI device.
Terumo Cardiovascular Systems Corporation
804981
In Commercial Distribution

  • 00886799000830 ()
804981

  • Cardiopulmonary bypass system mounting unit
The occluder module serves as the interface between the occluder head and the system. The occluder system is controlled from the CCM, and can be configured to respond to primary pump events.
Terumo Cardiovascular Systems Corporation
803480
In Commercial Distribution

  • 00886799000779 ()
803480

  • Cardiopulmonary bypass system, roller type
The Interface Module for CDI 500 Module provides the interface between the CDI™ 500 Blood Parameter Monitoring System and the APS1. The module communicates the CDI 500 monitor values to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
803479
In Commercial Distribution

  • 00886799000762 ()
803479

  • Cardiopulmonary bypass system, roller type
The Interface Module for CDI 100 provides the interface between a CDI ™ 100 or CDI™ 100 Saturation/Hematocrit Monitor and the APS1. The module communicates the CDI monitor values to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
802558
In Commercial Distribution

  • 00886799000755 ()
802558

  • Cardiopulmonary bypass system, roller type
The interface between the temperature sensor and the rest of the system.
Terumo Cardiovascular Systems Corporation
802114
In Commercial Distribution

  • 00886799000748 ()
802114

  • Cardiopulmonary bypass system, roller type
The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
Terumo Cardiovascular Systems Corporation
802113
In Commercial Distribution

  • 00886799000731 ()
802113

  • Cardiopulmonary bypass system, roller type
The pressure module serves as the interface between up to two pressure transducers and the system. This module monitors signals from the pressure transducers and communicates pressure values, alerts, and alarms to the system.
Terumo Cardiovascular Systems Corporation
802112
In Commercial Distribution

  • 00886799000724 ()
802112

  • Cardiopulmonary bypass system, roller type
The flowmeter module provides the interface between the flow sensor and the system. The module processes the signals necessary to compute fluid flow values. Those flow values are then communicated to the system. Flowmeter values are displayed on the CCM and, if assigned, on a pump's local display.
Terumo Cardiovascular Systems Corporation
802018
In Commercial Distribution

  • 00886799000687 ()
802018

  • Cardiopulmonary bypass system, roller type
The 15" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles
Terumo Cardiovascular Systems Corporation
801558
In Commercial Distribution

  • 00886799000649 ()
801558

  • Desk mount
The 33" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles
Terumo Cardiovascular Systems Corporation
801238
In Commercial Distribution

  • 00886799000595 ()
801238

  • Desk mount
Experience the next level of pain relief with the Brace Direct BlueIce Cold Cryotherapy Machine. Perfect for arthritis, post-surgical recovery, and injury treatment, this machine combines portability and efficiency for targeted cold therapy.
BRACE ALIGN LLC
CTY243
In Commercial Distribution

  • 00689481624044 ()


  • Circulating-fluid localized thermal therapy system
NITRONOX,HOSPITAL W/DEM VALVE
PARKER-HANNIFIN CORPORATION
NOX-5000HD
In Commercial Distribution

  • 00816711020387 ()


  • Inhalational analgesia unit
NITRONOX INHALATION ANALGESIA
PARKER-HANNIFIN CORPORATION
NOX-5000H
In Commercial Distribution

  • 00816711020370 ()


  • Inhalational analgesia unit
Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
PRESERVATION SOLUTIONS INC
BTLBMPS-1000
In Commercial Distribution

  • 10810805000108 ()
  • 00810805000101 ()

  • Total Volume: 1000 Milliliter


  • Donor-organ/tissue/cell preservation solution
Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
PRESERVATION SOLUTIONS INC
MPS-001
In Commercial Distribution

  • 10810805000092 ()
  • 00810805000095 ()

  • Total Volume: 1000 Milliliter


  • Donor-organ/tissue/cell preservation solution
No Description
Beijing ADSS Development Co., Ltd.
FG 2010-C
In Commercial Distribution

  • 06970453270142 ()


  • Dermatological frequency-doubled solid-state laser system
No Description
Beijing ADSS Development Co., Ltd.
FG 2010-B
In Commercial Distribution

  • 06970453270135 ()


  • Dermatological frequency-doubled solid-state laser system
No Description
Beijing ADSS Development Co., Ltd.
FG 2010
In Commercial Distribution

  • 06970453270012 ()


  • Dermatological frequency-doubled solid-state laser system
No Description
BIO CONCEPT Co., Ltd.
353260
In Commercial Distribution

  • 06947600316299 ()


  • Surgical screwdriver, reusable
No Description
BIO CONCEPT Co., Ltd.
353250
In Commercial Distribution

  • 06947600316282 ()


  • Surgical screwdriver, reusable
No Description
BIO CONCEPT Co., Ltd.
353240
In Commercial Distribution

  • 06947600316275 ()


  • Surgical screwdriver, reusable
No Description
BIO CONCEPT Co., Ltd.
353230
In Commercial Distribution

  • 06947600316268 ()


  • Surgical screwdriver, reusable
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