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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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TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution

  • 00860003469842 ()
LLO00002GR

  • Air-conduction hearing aid, receiver-in-canal
No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution

  • 10860003469801 ()
  • 00860003469804 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear
ClearFit VDI Large
LONGEVITI NEURO SOLUTIONS LLC
171718
In Commercial Distribution

  • 00860003416310 ()


  • Cranial resinous compound
ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution

  • 00860003416303 ()


  • Cranial resinous compound
Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution

  • 00860003372906 ()


  • Natural conception assistance kit
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
None
In Commercial Distribution

  • 00860003340608 ()


  • Infusion pump medication-dosage application software
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