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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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LifeSignals - B353LP12511

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

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

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

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


  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

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

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

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

  • Electrocardiographic ambulatory recorder

C6 monitor - B146M10

No Description
BRAEMAR MANUFACTURING, LLC
100-0046-02
In Commercial Distribution

  • B146M10 ()


  • Electrocardiographic ambulatory recorder

ER9W Cardiolabs - B146ERWCD040

No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.0 rebuilt - B146EP2R10

No Description
BRAEMAR MANUFACTURING, LLC
02-01997
In Commercial Distribution

  • B146EP2R10 ()


  • Electrocardiographic ambulatory recorder

ePatch Sensor 2.5, Rebuilt - B146EP25R0

No Description
BRAEMAR MANUFACTURING, LLC
02-02251
In Commercial Distribution

  • B146EP25R0 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.5, BTI - B146EP2520

No Description
BRAEMAR MANUFACTURING, LLC
02-02046
In Commercial Distribution

  • B146EP2520 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.5, BTH - B146EP2510

No Description
BRAEMAR MANUFACTURING, LLC
02-02045
In Commercial Distribution

  • B146EP2510 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.0 BTI - B146EP2020

No Description
BRAEMAR MANUFACTURING, LLC
02-01650
In Commercial Distribution

  • B146EP2020 ()


  • Electrocardiographic ambulatory recorder

Epatch 2.0 - B146EP2010

No Description
BRAEMAR MANUFACTURING, LLC
02-01575
In Commercial Distribution

  • B146EP2010 ()


  • Electrocardiographic ambulatory recorder

Epatch Sensor - B146EP080

No Description
BRAEMAR MANUFACTURING, LLC
900-0632-05
In Commercial Distribution

  • B146EP080 ()


  • Electrocardiographic ambulatory recorder

Epatch Sensor - B146EP070

No Description
BRAEMAR MANUFACTURING, LLC
900-0632-04
In Commercial Distribution

  • B146EP070 ()


  • Electrocardiographic ambulatory recorder

Epatch Sensor - B146EP060

No Description
BRAEMAR MANUFACTURING, LLC
900-0632-03
In Commercial Distribution

  • B146EP060 ()


  • Electrocardiographic ambulatory recorder

Epatch Sensor - B146EP04

No Description
BRAEMAR MANUFACTURING, LLC
900-0632-02
In Commercial Distribution

  • B146EP04 ()


  • Electrocardiographic ambulatory recorder

Epatch sensor - B146EP030

No Description
BRAEMAR MANUFACTURING, LLC
900-0632-01
In Commercial Distribution

  • B146EP030 ()


  • Electrocardiographic ambulatory recorder

ePatch - B146EP020

ePatch Holter Device
BRAEMAR MANUFACTURING, LLC
900-0632-00
In Commercial Distribution

  • B146EP020 ()


  • Electrocardiographic ambulatory recorder

ePatch - B146EP010

ePatch Holter Device
BRAEMAR MANUFACTURING, LLC
900-0630-00
In Commercial Distribution

  • B146EP010 ()


  • Electrocardiographic ambulatory recorder

BTP-1000LW - B146ELWA10

No Description
BRAEMAR MANUFACTURING, LLC
02-00124
In Commercial Distribution

  • B146ELWA10 ()


  • Electrocardiographic ambulatory recorder

DL900 - B146DL9ZW0

No Description
BRAEMAR MANUFACTURING, LLC
900-0570-25
In Commercial Distribution

  • B146DL9ZW0 ()


  • Electrocardiographic ambulatory recorder

DL900 Standard - B146DL9ST0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-27
In Commercial Distribution

  • B146DL9ST0 ()


  • Electrocardiographic ambulatory recorder

DL900 Remote Analysis - B146DL9RA0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-14
In Commercial Distribution

  • B146DL9RA0 ()


  • Electrocardiographic ambulatory recorder

DL900 Norav 7 day CE - B146DL9NV0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-15
In Commercial Distribution

  • B146DL9NV0 ()


  • Electrocardiographic ambulatory recorder

DL900 Norav Encrypted - B146DL9NE0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-24
In Commercial Distribution

  • B146DL9NE0 ()


  • Electrocardiographic ambulatory recorder

DL900 Forest Medical - B146DL9FM0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-23
In Commercial Distribution

  • B146DL9FM0 ()


  • Electrocardiographic ambulatory recorder

DL900 Base - B146DL9BS0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-26
In Commercial Distribution

  • B146DL9BS0 ()


  • Electrocardiographic ambulatory recorder

DL900 Burdick 4250 - B146DL9BK0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-19
In Commercial Distribution

  • B146DL9BK0 ()


  • Electrocardiographic ambulatory recorder

DL900 Biomedical SyS - B146DL9BD0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-20
In Commercial Distribution

  • B146DL9BD0 ()


  • Electrocardiographic ambulatory recorder

DL900 Braemar 7day - B146DL9B70

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-16
In Commercial Distribution

  • B146DL9B70 ()


  • Electrocardiographic ambulatory recorder

DL900 Braemar SD - B146DL9B0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-10
In Commercial Distribution

  • B146DL9B0 ()


  • Electrocardiographic ambulatory recorder

DL900 Amedtec SD - B146DL9AT0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0570-12
In Commercial Distribution

  • B146DL9AT0 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar Standard - B146DL95030

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-03
In Commercial Distribution

  • B146DL95030 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar Base - B146DL95020

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-02
In Commercial Distribution

  • B146DL95020 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar - B146DL95010

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-01
In Commercial Distribution

  • B146DL95010 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar - B146DL95000

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-00
In Commercial Distribution

  • B146DL95000 ()


  • Electrocardiographic ambulatory recorder

DL900 - B146DL9280

No Description
BRAEMAR MANUFACTURING, LLC
900-0570-28
In Commercial Distribution

  • B146DL9280 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav Encrypted - B146DL8NVE0

DL800 Holter recorder
BRAEMAR MANUFACTURING, LLC
900-0543-21
In Commercial Distribution

  • B146DL8NVE0 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav - B146DL8NV0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-20
In Commercial Distribution

  • B146DL8NV0 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav 256 s/s 8bit - B146DL8NO2560

Holter Monitor
BRAEMAR MANUFACTURING, LLC
900-0543-12
In Commercial Distribution

  • B146DL8NO2560 ()


  • Electrocardiographic ambulatory recorder
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