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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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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
OCS Wireless Monitor, Universal
TRANSMEDICS, INC.
2450
In Commercial Distribution

  • B00939301 ()
  • B00939270 ()

  • Height: 3.5 Inch
  • Width: 8.5 Inch
  • Length: 9.5 Inch
2450

  • Donor-organ preservation/transport system control unit
OCS Wireless Monitor, Heart
TRANSMEDICS, INC.
1410
In Commercial Distribution

  • B00913390 ()
  • B00926311 ()

  • Length: 9.5 Inch
  • Width: 8.5 Inch
  • Height: 3.5 Inch
1410

  • Donor-organ preservation/transport system control unit
No Description
SteadySense GmbH
1
In Commercial Distribution

  • 09120095900281 ()


  • 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
Radius T Continuous Thermometer
MASIMO CORPORATION
4823
In Commercial Distribution

  • 00843997004473 ()


  • Wireless patient thermometer, single-use
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
No Description
Natus Medical Denmark ApS
Specula 3mm normal
In Commercial Distribution

  • 05713315000065 ()


  • Auditory canal scanner
No Description
Natus Medical Denmark ApS
Otocam 300
In Commercial Distribution

  • 05713315000041 ()
8-04-13250

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

  • 05713315010699 ()
043243

  • Auditory canal scanner
1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription
Natus Medical Denmark ApS
043244
In Commercial Distribution

  • 05713315011054 ()
043244

  • 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
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
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