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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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EXD-001 Battery, Single
Avertix Medical Inc.
0203-2100-006
In Commercial Distribution

  • 00850012625155 ()
0203-2100-006

  • Primary battery
PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software
PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software
PROG-003 USB Flash Drive
Avertix Medical Inc.
0204-2100-077#P10
In Commercial Distribution

  • 00850012625124 ()
0204-2100-077#P10

  • Implantable cardiac device management application software
PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution

  • 00850012625100 ()
0204-2100-093#P10

  • Implantable cardiac device management application software
PROG-003 Serial Cable (10 foot)
Avertix Medical Inc.
0204-2100-112
In Commercial Distribution

  • 00850012625094 ()
0204-2100-112

  • Implantable cardiac device management application software
PROG-003 Serial Cable (6 foot)
Avertix Medical Inc.
0204-2100-085#P10
In Commercial Distribution

  • 00850012625087 ()
0204-2100-085#P10

  • Implantable cardiac device management application software
PROG-003 Wand
Avertix Medical Inc.
0204-2100-067#P15
In Commercial Distribution

  • 00850012625070 ()
0204-2100-067#P15

  • Implantable cardiac monitor programmer/transmitter/alarm
PROG-003 Kit (US)
Avertix Medical Inc.
0204-2100-075#P16
In Commercial Distribution

  • 00850012625063 ()
0204-2100-075#P16

  • Implantable cardiac device management application software
EXD Lanyard
Avertix Medical Inc.
0203-2100-003
In Commercial Distribution

  • 00850012625056 ()
0203-2100-003

  • Implantable cardiac monitor programmer/transmitter/alarm
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