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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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AccuRelief - 00023601291011

App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system

AccuRelief - 00023601091000

App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Drive - 00822383227788

APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable

Navina™ Smart App for Android - 07392532242380

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07392532242373

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software

Meridian Medical - 00815067040179

APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable

HANSATON stream remote 5.X - 07613389610932

A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software

BioPure 4400 RO - 00817492021969

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution

  • 00817492021969 ()

  • Width: 38 Inch
  • Depth: 29 Inch
  • Height: 80.5 Inch
  • Weight: 783 Pound


  • Reverse-osmosis water purification system

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311029119

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution

  • 00812311029119 ()


  • Multi-chamber venous compression system garment, reusable

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311020062

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution

  • 00812311020062 ()


  • Multi-chamber venous compression system garment, reusable
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