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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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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

BTP-1000S - B146C6S0

MCOT Holter
BRAEMAR MANUFACTURING, LLC
900-0634-00
In Commercial Distribution

  • B146C6S0 ()


  • Electrocardiographic ambulatory recorder

C6 Sensor 3.0, Rebuilt - B146C6R30

No Description
BRAEMAR MANUFACTURING, LLC
02-02124
In Commercial Distribution

  • B146C6R30 ()


  • Electrocardiographic ambulatory recorder

C6 Sensor 2.0 rebuilt - B146C6R20

No Description
BRAEMAR MANUFACTURING, LLC
02-01897
In Commercial Distribution

  • B146C6R20 ()


  • Electrocardiographic ambulatory recorder

C6 Sensor 2.5 rebuilt - B146C6R10

No Description
BRAEMAR MANUFACTURING, LLC
02-01889
In Commercial Distribution

  • B146C6R10 ()


  • Electrocardiographic ambulatory recorder
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