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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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Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 12, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50262
In Commercial Distribution

  • 05708932282918 ()
  • 05708932279154 ()

  • Catheter Gauge: 12 French
  • Catheter Working Length: 31 Centimeter
  • Tip Type Straight/Nelaton
  • Catheter Working Length: 12.2 Inch
50262

  • Single-administration urethral catheterization kit, single-use
Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 10, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50261
In Commercial Distribution

  • 05708932282901 ()
  • 05708932279147 ()

  • Catheter Gauge: 10 French
  • Catheter Working Length: 12.2 Inch
  • Tip Type Straight/Nelaton
  • Catheter Working Length: 31 Centimeter
50261

  • Single-administration urethral catheterization kit, single-use
Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 8, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50260
In Commercial Distribution

  • 05708932282895 ()
  • 05708932279130 ()

  • Catheter Gauge: 8 French
  • Catheter Working Length: 31 Centimeter
  • Catheter Working Length: 12.2 Inch
  • Tip Type Straight/Nelaton
50260

  • Single-administration urethral catheterization kit, single-use
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
No Description
ALIMED, INC.
910433ZBW
In Commercial Distribution

  • 00733657259315 ()
2970011579

  • Operating table mattress, basic
Welch Allyn 3.5 V Halogen HPX Ophthalmoscope Set with Coaxial Ophthalmoscope (#11720), Rechargeable 60-Minute Power Handle(s) -- C-C ell Convertible, Hard Storage Case, C-Cell Battery Converter Accessory; Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F
WELCH ALLYN, INC.
901081
In Commercial Distribution

  • 00732094019643 ()
11772-VC

  • Ophthalmic/otologic diagnostic set
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
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
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
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
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