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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Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution

  • 10884521821545 ()


  • Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0145
In Commercial Distribution

  • 00815381020185 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0144
In Commercial Distribution

  • 00815381020178 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Heidelberg pH capsule system software package intended to add image processing and/or analysis capabilities to a gastric and gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastric and gastrointestinal pH via wirelessly transmitted signals from a pH telemetric capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data that is transmitted by a transceiver.
Heidelberg Medical Inc
Heidelberg pH Capsule System Software
In Commercial Distribution

  • B989HCNS180 ()
HCNS18

  • Gastrointestinal telemetric monitoring system application software
Gastric Alimetry Kit
ALIMETRY LIMITED
AK001-A
In Commercial Distribution

  • 09421906857122 ()


  • Myoelectric gastrointestinal motility analysis system
Gastric Alimetry Dock
ALIMETRY LIMITED
AD001
In Commercial Distribution

  • 09421906857030 ()


  • Myoelectric gastrointestinal motility analysis system
Gastric Alimetry Array
ALIMETRY LIMITED
AS001-1
In Commercial Distribution

  • 09421906857023 ()
  • 09421906857016 ()
  • 09421906857108 ()


  • Myoelectric gastrointestinal motility analysis system
Alimetry Reader
ALIMETRY LIMITED
AL001-A
In Commercial Distribution

  • 09421906857009 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research/Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000292 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
Disposable Electrode and Lead Set for use with 3CPM EGG System, 40pk
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000278 ()


  • Myoelectric gastrointestinal motility analysis system
6' leads for use with EGG system
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000261 ()


  • Myoelectric gastrointestinal motility analysis system
Respiratory Belt for 3CPM Electrogastrography system
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000254 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
Human Interface Device
3CPM CO., INC.
1.02
In Commercial Distribution

  • 00864359000230 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000216 ()


  • Myoelectric gastrointestinal motility analysis system
The 3CPM Company, Inc Electrogastrogram Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000209 ()


  • Myoelectric gastrointestinal motility analysis system
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006340 ()

  • Duration: 72 Hours
634

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006326 ()
632

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006319 ()
631

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006302 ()

  • Duration: 72 Hours
630

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006296 ()

  • Duration: 72 Hours


  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
Not in Commercial Distribution

  • 00851203006104 ()
  • 00851203006227 ()

  • Duration: 72 Hours
622

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006050 ()
  • 00851203006210 ()

  • Duration: 24 Hours
621

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006203 ()

  • Duration: 72 Hours
620

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006197 ()
  • 00851203006104 ()

  • Duration: 72 Hours
619

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006166 ()
  • 00851203006050 ()

  • Duration: 24 Hours


  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006074 ()
  • 00851203006104 ()

  • Duration: 72 Hours
607

  • Wireless patient thermometer, single-use
No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-200
In Commercial Distribution

  • 00851203006067 ()

  • Duration: 48 Hours
606

  • Wireless patient thermometer, single-use
Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006029 ()
  • 00851203006050 ()
602

  • Wireless patient thermometer, single-use
Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006012 ()
601

  • Wireless patient thermometer, single-use
Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006005 ()
600

  • Wireless patient thermometer, single-use
Radius T Adult/Pediatric Continuous Body Temperature Sensor
MASIMO CORPORATION
4776
In Commercial Distribution

  • 00843997016087 ()
  • 10843997016084 ()


  • Wireless patient thermometer, single-use
Radius T Continuous Thermometer
MASIMO CORPORATION
4823
In Commercial Distribution

  • 00843997004473 ()


  • Wireless patient thermometer, single-use
Radius T Sensor for Masimo SafetyNet
MASIMO CORPORATION
4779
In Commercial Distribution

  • 00843997016162 ()


  • Wireless patient thermometer, single-use
Radius PPG & Radius T for Masimo SafetyNet Kit
MASIMO CORPORATION
4778
In Commercial Distribution

  • 00843997016155 ()


  • Wireless patient thermometer, single-use
No Description
SteadySense GmbH
1
In Commercial Distribution

  • 09120095900281 ()


  • Wireless patient thermometer, single-use
1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription
Natus Medical Denmark ApS
043244
In Commercial Distribution

  • 05713315011054 ()
043244

  • Auditory canal scanner
1093,OTOSCAN Bundle – Scanner & Headset without laptop
Natus Medical Denmark ApS
043243
In Commercial Distribution

  • 05713315010699 ()
043243

  • Auditory canal scanner
1093 Desktop Cradle
Natus Medical Denmark ApS
8-35-42400
In Commercial Distribution

  • 05713315008436 ()
8-35-42400

  • Auditory canal scanner
1093 HS3 Headset
Natus Medical Denmark ApS
8-35-49300
In Commercial Distribution

  • 05713315008429 ()
8-35-49300

  • Auditory canal scanner
No Description
Natus Medical Denmark ApS
1093, Headset HS3
In Commercial Distribution

  • 05713315006005 ()
8-61-20200

  • Auditory canal scanner
1093, DESKTOP CRADLE, ACCESSORY
Natus Medical Denmark ApS
8-61-20100
In Commercial Distribution

  • 05713315005992 ()
8-61-20100

  • Auditory canal scanner
No Description
Natus Medical Denmark ApS
1093, Otoscan Instrument
In Commercial Distribution

  • 05713315005886 ()
8-04-15400

  • Auditory canal scanner
No Description
Natus Medical Denmark ApS
Desktop Cradle
In Commercial Distribution

  • 05713315000089 ()
8-35-30800

  • Auditory canal scanner
No Description
Natus Medical Denmark ApS
Specula 3 mm Cerumen
In Commercial Distribution

  • 05713315000072 ()


  • Auditory canal scanner
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