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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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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

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

Drive - 00822383580913

Symphony True LAL & APP Matt Repl Sys
Drive Devilbiss Healthcare
14500
Not in Commercial Distribution

  • 00822383580913 ()


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

Navina™ Smart App for Android - 07333387030395

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07333387030388

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software

Guardian™ Connect App - 00763000186333

SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software

InPen - 00763000974596

SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical

InPen - 00763000974589

SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical
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