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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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Glucometer Control Solution - A/B Pack
Tenovi Co.
TE-CTR-P1
In Commercial Distribution

  • 00860008115942 ()


  • Glucose monitoring system IVD, home-use
Glucometer Control Solution - B
Tenovi Co.
TE-CTR-B1
In Commercial Distribution

  • 00860008115935 ()


  • Glucose monitoring system IVD, home-use
Glucometer Control Solution
Tenovi Co.
TE-CTR-A1
In Commercial Distribution

  • 00860008115928 ()


  • Glucose monitoring system IVD, home-use
Glucometer Test Strips (50 Pack)
Tenovi Co.
TE-STR-A1
In Commercial Distribution

  • 00860008115911 ()


  • Glucose IVD, reagent
Bluetooth Blood Glucose Monitoring System
Tenovi Co.
TE-KIT-A1
In Commercial Distribution

  • 00860008115904 ()


  • Glucose monitoring system IVD, home-use
No Description
Lumebox LLC
LB-001A
In Commercial Distribution

  • 00860008109217 ()


  • Blue/red/infrared phototherapy lamp
The Strike Force from Power Soccer Shop is the first wheelchair designed specifically for power soccer! Designed with a low center of gravity and wide wheelbase, the Strike Force is able to move with more agility and spin kick with more power than any other power wheelchair in the world! Equipped with top-notch components and built on a durable steel frame, this chair is ready for the rigors of elite competition.
Northern Engineering and Manufacturing, Inc.
1633
In Commercial Distribution

  • 00860008065407 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable
The AqueCool Upper Face and Eyes Mask (UFAE) is a wearable, water circulating face mask. It covers from below the eyes to the top of the forehead and can provide compression. Embedded wire splint and flexible ear patches allow form-fitting to each user’s face. Eye Flaps can be secured in an upright position for visibility or can be brought down to assist in total facial recovery. When used in conjunction with the AqueCool Device, the mask delivers cool water within the wearable bladder, wicking excess heat away from recovering tissue. Storage Temperature < 45C
Advanced Ambulatory, Inc.
1.0
In Commercial Distribution

  • 00860008048363 ()
  • 00860008048332 ()


  • Circulating-fluid localized thermal therapy system pack, single-use
The AqueCool Lower Face and Neck Mask (LFAN) is a wearable water circulating face mask. It covers from below the jawline up to the top of the cheek and can provide compression. Embedded wire splints and flexible chin and ear patches allow form-fitting to each user’s face. When used in conjunction with the AqueCool Device, the mask delivers cool water within the wearable bladder, wicking excess heat away from recovering tissue. Storage Temperature < 45C
Advanced Ambulatory, Inc.
1.0
In Commercial Distribution

  • 00860008048356 ()
  • 00860008048325 ()


  • Circulating-fluid localized thermal therapy system pack, single-use
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