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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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Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Large Hydrokit
In Commercial Distribution

  • B482Z091 ()
  • B482Z090 ()
  • B482Z092 ()
Z-09

  • Colonic lavage kit, non-surgical
DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device
DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

  • B626100030 ()
  • B626100031 ()
  • B626100032 ()
10003

  • Drawing-test cognitive function analysis device
No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable
Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
MAC Strap-petite
Recovery Force, LLC
1
In Commercial Distribution

  • B547RF14230 ()
  • B547RF14237 ()
  • B547RF144023 ()

  • Length: 432 Millimeter
RF1423

  • Intermittent venous compression system
MAC Strap-Bariatric
Recovery Force, LLC
4
In Commercial Distribution

  • B547RF14227 ()
  • B547RF14220 ()
  • B547RF14402270 ()

  • Length: 921 Millimeter
RF1422

  • Intermittent venous compression system
MAC Strap-XL
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14217 ()
  • B547RF14210 ()
  • B547RF1440219 ()

  • Length: 743 Millimeter
RF1421

  • Intermittent venous compression system
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