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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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The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable
Pro - Direct Adult Mac 4 Blade
One-AI Healthcare, Inc
Pro - Direct Adult Mac 4 Blade
In Commercial Distribution

  • 00860010859766 ()


  • Video intubation laryngoscope blade
Pro - Angulated Adult Size 4 Blade
One-AI Healthcare, Inc
Pro - Angulated Adult Size 4 Blade
In Commercial Distribution

  • 00860010859759 ()


  • Video intubation laryngoscope blade
Pro - Direct Adult Mac 3 Blade
One-AI Healthcare, Inc
Pro - Direct Adult Mac 3 Blade
In Commercial Distribution

  • 00860010859742 ()


  • Video intubation laryngoscope blade
Pro - Angulated Adult Size 3 Blade
One-AI Healthcare, Inc
Pro - Angulated Adult Size 3 Blade
In Commercial Distribution

  • 00860010859735 ()


  • Video intubation laryngoscope blade
Pro - Pediatric Size 2 Blade
One-AI Healthcare, Inc
Pro - Pediatric Size 2 Blade
In Commercial Distribution

  • 00860010859728 ()


  • Video intubation laryngoscope blade
Pro - Neonatal Size 1 Blade
One-AI Healthcare, Inc
Pro - Neonatal Size 1 Blade
In Commercial Distribution

  • 00860010859711 ()
3010001

  • Video intubation laryngoscope blade
OneScope Pro Video Laryngoscope
One-AI Healthcare, Inc
OneScope Pro Video Laryngoscope
In Commercial Distribution

  • 00860010859704 ()


  • Video intubation laryngoscope handle/monitor
Everyday Carry Tourniquet Wide (ETQ-W) - Gen 1 - 1.5" - Black
Snakestaff Systems, LLC
ETQ-W-G1
In Commercial Distribution

  • 00860010714812 ()
ETQ-W

  • Limb tourniquet, manual, single-use
Everyday Carry Tourniquet (ETQ) - Gen 1 - 1.0" - Black
Snakestaff Systems, LLC
ETQ-G1
In Commercial Distribution

  • 00860010714805 ()
ETQ

  • Limb tourniquet, manual, single-use
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