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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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Diversatek Healthcare - 00816734021682

Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-1070
In Commercial Distribution

  • 10816734021689 ()
  • 00816734021682 ()
  • B019A8610700 ()
A86-1070

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021675

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04-2000-S
In Commercial Distribution

  • 00816734021675 ()
  • B019A042000S0 ()
A04-2000-S

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021668

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04R-2500
In Commercial Distribution

  • 00816734021668 ()
  • B019A04R25000 ()
A04R-2500

  • Manometric gastrointestinal motility analysis system

Bolt - B35000500R0

Bolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00500R
In Commercial Distribution

  • B35000500R0 ()
00500R

  • Enzyme immunoassay (EIA) analyser IVD

Bolt - B350005000

Bolt EIA
Gold Standard Diagnostics Corporation
00500
In Commercial Distribution

  • B350005000 ()
00500

  • Enzyme immunoassay (EIA) analyser IVD

ThunderBolt EIA - B35000300R0

ThunderBolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00300R
In Commercial Distribution

  • B35000300R0 ()
00300R

  • Enzyme immunoassay (EIA) analyser IVD

ThunderBolt EIA - B350003000

No Description
Gold Standard Diagnostics Corporation
00300
In Commercial Distribution

  • B350003000 ()
00300

  • Enzyme immunoassay (EIA) analyser IVD

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB12511

1AXe Wearable Biosensor
Lifesignals, Inc.
UB1251
In Commercial Distribution

  • B353UB12512 ()
  • B353UB12511 ()
  • B353UB12513 ()


  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder
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