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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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Heidelberg pH Capsule System - B989HCNS180

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

GN Otometrics A/S - 05713315000089

No Description
Natus Medical Denmark ApS
Desktop Cradle
In Commercial Distribution

  • 05713315000089 ()
8-35-30800

  • Auditory canal scanner

GN Otometrics A/S - 05713315000072

No Description
Natus Medical Denmark ApS
Specula 3 mm Cerumen
In Commercial Distribution

  • 05713315000072 ()


  • Auditory canal scanner

GN Otometrics A/S - 05713315000065

No Description
Natus Medical Denmark ApS
Specula 3mm normal
In Commercial Distribution

  • 05713315000065 ()


  • Auditory canal scanner

GN Otometrics A/S - 05713315000041

No Description
Natus Medical Denmark ApS
Otocam 300
In Commercial Distribution

  • 05713315000041 ()
8-04-13250

  • Auditory canal scanner

Natus - 05713315005992

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

  • 05713315005992 ()
8-61-20100

  • Auditory canal scanner

TempTraq® - 00851203006340

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006340 ()

  • Duration: 72 Hours
634

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006326

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006326 ()
632

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006319

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006319 ()
631

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006302

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006302 ()

  • Duration: 72 Hours
630

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006296

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006296 ()

  • Duration: 72 Hours


  • Wireless patient thermometer, single-use

Cell Therapy 360 Wearable Tech V1 - 00851203006227

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
Not in Commercial Distribution

  • 00851203006104 ()
  • 00851203006227 ()

  • Duration: 72 Hours
622

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006210

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006050 ()
  • 00851203006210 ()

  • Duration: 24 Hours
621

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006203

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006203 ()

  • Duration: 72 Hours
620

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006197

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006197 ()
  • 00851203006104 ()

  • Duration: 72 Hours
619

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006166

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006166 ()
  • 00851203006050 ()

  • Duration: 24 Hours


  • Wireless patient thermometer, single-use

TempTraq® - 00851203006074

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006074 ()
  • 00851203006104 ()

  • Duration: 72 Hours
607

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006067

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-200
In Commercial Distribution

  • 00851203006067 ()

  • Duration: 48 Hours
606

  • Wireless patient thermometer, single-use

TempTraq - 00851203006029

Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006029 ()
  • 00851203006050 ()
602

  • Wireless patient thermometer, single-use

TempTraq - 00851203006012

Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006012 ()
601

  • Wireless patient thermometer, single-use

TempTraq - 00851203006005

Continuous Temperature Monitor
BLUE SPARK TECHNOLOGIES, INC.
TT-100
In Commercial Distribution

  • 00851203006005 ()
600

  • Wireless patient thermometer, single-use

Otoscan - 05713315011054

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

  • 05713315011054 ()
043244

  • Auditory canal scanner

Otoscan - 05713315010699

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

  • 05713315010699 ()
043243

  • Auditory canal scanner

Natus - 05713315008436

1093 Desktop Cradle
Natus Medical Denmark ApS
8-35-42400
In Commercial Distribution

  • 05713315008436 ()
8-35-42400

  • Auditory canal scanner

Natus - 05713315008429

1093 HS3 Headset
Natus Medical Denmark ApS
8-35-49300
In Commercial Distribution

  • 05713315008429 ()
8-35-49300

  • Auditory canal scanner

GN Otometrics A/S - 05713315006005

No Description
Natus Medical Denmark ApS
1093, Headset HS3
In Commercial Distribution

  • 05713315006005 ()
8-61-20200

  • Auditory canal scanner

GN Otometrics A/S - 05713315005886

No Description
Natus Medical Denmark ApS
1093, Otoscan Instrument
In Commercial Distribution

  • 05713315005886 ()
8-04-15400

  • Auditory canal scanner

Radius T - 10843997016084

Radius T Adult/Pediatric Continuous Body Temperature Sensor
MASIMO CORPORATION
4776
In Commercial Distribution

  • 00843997016087 ()
  • 10843997016084 ()


  • Wireless patient thermometer, single-use

TempShield - 00197644811199

The TempShield is a wearable device that senses body temperature and communicates with an app on your smartphone. When the TempShield is connected to your device, it sends all temperature measurements automatically. You can wear an TempShield for up to 60 days and check your current temperature and temperature measurements history at any time. You have the ability to share the data with your clinician if your clinician has established an AION account.
Aion Biosystems, Inc.
DWF-1824
In Commercial Distribution

  • 00197644811199 ()


  • Wireless patient thermometer, single-use

Radius T - 00843997004473

Radius T Continuous Thermometer
MASIMO CORPORATION
4823
In Commercial Distribution

  • 00843997004473 ()


  • Wireless patient thermometer, single-use
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