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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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Easy Comfort Safety Pen Needles 31G 5mm
HOME AIDE DIAGNOSTICS, INC.
7878
In Commercial Distribution

  • 10860006377875 ()
  • 00860006377878 ()

  • Needle Gauge: 31 Gauge


  • Subcutaneous infusion/injection port needle
Easy Comfort Safety Pen Needles 32G 4mm
HOME AIDE DIAGNOSTICS, INC.
7861
In Commercial Distribution

  • 10860006377868 ()
  • 00860006377861 ()

  • Needle Gauge: 32 Gauge


  • Subcutaneous infusion/injection port needle
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
TrueCSafety50
In Commercial Distribution

  • 10860006377851 ()
  • 00860006377854 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
TrueCSafety100
In Commercial Distribution

  • 10860006377844 ()
  • 00860006377847 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
One handed use No lancing device required Automatic needle retraction Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
PureCSafety50
In Commercial Distribution

  • 10860006377813 ()
  • 00860006377816 ()

  • Needle Gauge: 30 Gauge


  • Manual blood lancing device, single-use
Chlorine Sentinel II is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. It detects dissolved combined chlorine in concentrations at or above 10 PPB by primary detection technology. It self-monitors for maintenance-required conditions and loss of electrical power. The Chlorine Sentinel II is self-testing. It uses chlorinated city water to automatically test the chlorine detecting functionality of the device once a day and records if the test passed, failed to detect chlorine, or didn’t rinse out after detecting chlorine. The device is designed to use as little water as possible. The sampling water is only used for the length of time that it takes for the chlorine test to be completed. The customer determines how frequently the test needs to be taken from every 5 minutes to every 20 minutes. The user also sets the start time and end time for each day of the week. The Chlorine Sentinel II has two combined chlorine concentration set points. The user can set a warning set-point at a value of 0.01 PPM to 0.09 PPM. Once the chlorine concentration exceeds this value, the device will alarm at 2-HZ to warn the user of chlorine present at that set-point. The second set-point is factory set at 0.10 PPM. A chlorine concentration equal to or above the 0.10 PPM set-point will activate the buzzers and the red chlorine alarm indicators at 5 HZ for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The alarms can be by-passed. When by-passed the pulsing lights will turn solid and the buzzer will double click over 15 minutes. The front cover of the device has two screens. The screen of the chlorine monitor indicates the presence of combined chlorine when the value is not 0.000. The touch screen is used to enter user data and show the statuses of the device.
Nelson Environmental Technologies Inc
NSS-CS-II-001
In Commercial Distribution

  • 00860006352165 ()


  • Haemodialysis system chlorine monitor
Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water.
Nelson Environmental Technologies Inc
Complete System
In Commercial Distribution

  • 00860006352127 ()


  • Combination water purification system
The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop. The device has three components – a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area. A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller. A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.
Nelson Environmental Technologies Inc
NSS-BCS-001
In Commercial Distribution

  • 00860006352103 ()


  • Haemodialysis system chlorine monitor
InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorganizes images according to relevant categorical attributes, and syncs all related views for current and prior studies.
Ascend Cardiovascular LLC
9.0
In Commercial Distribution

  • 00860006348021 ()


  • Radiology DICOM image processing application software
ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.
Ascend Cardiovascular LLC
9.5
In Commercial Distribution



  • Radiology DICOM image processing application software
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