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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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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

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 Remote Analysis - B146DL9RA0

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

  • B146DL9RA0 ()


  • Electrocardiographic ambulatory recorder

DL900 Norav Encrypted - B146DL9NE0

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

  • B146DL9NE0 ()


  • Electrocardiographic ambulatory recorder

DL900 Base - B146DL9BS0

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

  • B146DL9BS0 ()


  • 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 Forest Medical 256 s/s 8 bit - B146DL8FM0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-17
In Commercial Distribution

  • B146DL8FM0 ()


  • Electrocardiographic ambulatory recorder

DL800 CardioNet - B146DL8CN0

Holter Monitor
BRAEMAR MANUFACTURING, LLC
900-0543-15
In Commercial Distribution

  • B146DL8CN0 ()


  • Electrocardiographic ambulatory recorder

DL800 CardioLabs - B146DL8CL0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-11
In Commercial Distribution

  • B146DL8CL0 ()


  • Electrocardiographic ambulatory recorder

DL800 Biomedical SYS - B146DL8BD0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-19
In Commercial Distribution

  • B146DL8BD0 ()


  • Electrocardiographic ambulatory recorder

DL800 Braemar 133 s/s - B146DL8B1330

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-04
In Commercial Distribution

  • B146DL8B1330 ()


  • Electrocardiographic ambulatory recorder

DL800 Braemar 256 s/s 10 bit - B146DL8256B0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-09
In Commercial Distribution

  • B146DL8256B0 ()


  • Electrocardiographic ambulatory recorder

Cardiokey - B146CK0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
100-0030-01
In Commercial Distribution

  • B146CK0 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor UGW - B146C6M20

No Description
BRAEMAR MANUFACTURING, LLC
100-0048-02
In Commercial Distribution

  • B146C6M20 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345021684

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-AAA-XXXXX
In Commercial Distribution

  • 00812345021684 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021660

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-CAA-XXXXX
Not in Commercial Distribution

  • 00812345021660 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021653

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAA-XXXXX
Not in Commercial Distribution

  • 00812345021653 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021646

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AAA-XXXXX
Not in Commercial Distribution

  • 00812345021646 ()


  • Electrocardiographic ambulatory recorder

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

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

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

Smart ECG - 08031527017334

MicroPort CRM Smart ECG
MICROPORT CRM SRL
K379
In Commercial Distribution

  • 08031527017334 ()
K379

  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527015149

No Description
MICROPORT CRM SRL
Pouch
In Commercial Distribution

  • 08031527015149 ()


  • Electrocardiographic ambulatory recorder

CUSTODIA - 08031527015132

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527015132 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014890

No Description
MICROPORT CRM SRL
PLUS
In Commercial Distribution

  • 08031527014890 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW+ SD MEMORY CARD - 08031527014883

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527014883 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014876

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527014876 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW & SPIDERFLASH-T MEMORY CARD - 08031527013428

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527013428 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW SD MEMORY CARD - 08031527013411

No Description
MICROPORT CRM SRL
SD card
In Commercial Distribution

  • 08031527013411 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527013398

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527013398 ()


  • Electrocardiographic ambulatory recorder

Biotres Pro - B635BIOTRESPR0

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOTRESPR0 ()


  • Electrocardiographic ambulatory recorder

Mediblu - B632MDB01042

HA12P
MEDIBLU MEDICAL LLC
HA12P
In Commercial Distribution

  • B632MDB01042 ()
MDB01042

  • Electrocardiographic ambulatory recorder

Mediblu - B632MDB01024

No Description
MEDIBLU MEDICAL LLC
HP50P
In Commercial Distribution

  • B632MDB01024 ()
MDB01024

  • Arrythmia-detection blood pressure ambulatory recorder

Mediblu - B632MDB01023

No Description
MEDIBLU MEDICAL LLC
HA3P
In Commercial Distribution

  • B632MDB01023 ()
MDB01023

  • Electrocardiographic ambulatory recorder
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