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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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inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

ER920 Rozinn - B146ER9R0

ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution

  • B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&

  • Electrocardiography telemetric monitoring system

Welch Allyn, Inc. - 00732094244298

106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094244298 ()
106900

  • Centralized patient monitor

CONTOUR® NEXT ONE - 00301937818011

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.
ASCENSIA DIABETES CARE US INC.
7818
Not in Commercial Distribution

  • 00301937818011 ()
  • 0193-7818-01 ()
  • 40301937818019 ()
85012037

  • Glucose monitoring system IVD, home-use

Eko Core Attachment - 00863609000310

The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution

  • 00863609000310 ()


  • Electronic acoustic stethoscope

Eko Core Digital Attachment - 00850010298009

The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
E6
In Commercial Distribution

  • 00850010298009 ()


  • Electronic acoustic stethoscope

iSyncWave - 08800108500363

iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWaveTM App. The data is displayed and recorded via the iSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require a preparation process(e.g., applying conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWaveTM app. iSyncWaveTM can be only used by professional and/or medical personnel with product training and experience in EEG measurement. The professional and/or medical personnel can check the signal quality in real time and refer to the measured data in clinical practice.
iMediSync, Inc.
ISW-MUS101
In Commercial Distribution

  • 08800108500363 ()


  • Electroencephalograph

CONTOUR® NEXT ONE - 00301939765016

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9765
In Commercial Distribution

  • 40301939765014 ()
  • 00301939765016 ()
  • 0193-9765-01 ()
85602314

  • Glucose monitoring system IVD, home-use

TouchChat Express - 00816486020766

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package.
PRENTKE ROMICH COMPANY
TCE10.2
In Commercial Distribution

  • 00816486020766 ()


  • Voice synthesizer/digitizer

TouchChat Express - 00816486020544

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package
PRENTKE ROMICH COMPANY
TCE10.1
In Commercial Distribution

  • 00816486020544 ()

  • Weight: 1.9 Pound


  • Voice synthesizer/digitizer
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