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

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


  • Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder
Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder
Bolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00500R
In Commercial Distribution

  • B35000500R0 ()
00500R

  • Enzyme immunoassay (EIA) analyser IVD
Bolt EIA
Gold Standard Diagnostics Corporation
00500
In Commercial Distribution

  • B350005000 ()
00500

  • Enzyme immunoassay (EIA) analyser IVD
ThunderBolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00300R
In Commercial Distribution

  • B35000300R0 ()
00300R

  • Enzyme immunoassay (EIA) analyser IVD
No Description
Gold Standard Diagnostics Corporation
00300
In Commercial Distribution

  • B350003000 ()
00300

  • Enzyme immunoassay (EIA) analyser IVD
No Description
BRAEMAR MANUFACTURING, LLC
100-0046-02
In Commercial Distribution

  • B146M10 ()


  • Electrocardiographic ambulatory recorder
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