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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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inSIGHT Ultima - B019ULT1HI0

InSIGHT Ultima® HRiM2 System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-H-I
In Commercial Distribution

  • B019ULT1HI0 ()
ULT1-H-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HD0

InSIGHT Ultima® HRiM2 System
DIVERSATEK HEALTHCARE, INC.
ULT1-H-D
In Commercial Distribution

  • B019ULT1HD0 ()
ULT1-H-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HCAD0

inSIGHT Ultima® HRCA System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HCA-D
In Commercial Distribution

  • B019ULT1HCAD0 ()
ULT1-HCA-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HAI0

inSIGHT Ultima® HRaM System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HA-I
In Commercial Distribution

  • B019ULT1HAI0 ()
ULT1-HA-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HAD0

InSIGHT Ultima® HRaM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HA-D
In Commercial Distribution

  • B019ULT1HAD0 ()
ULT1-HA-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1CIED0

inSIGHT Ultima® Air-Charged Manometry System
DIVERSATEK HEALTHCARE, INC.
ULT1-CIE-D
In Commercial Distribution

  • B019ULT1CIED0 ()
ULT1-CIE-D

  • Manometric gastrointestinal motility analysis system

inSIGHT - B019H12R4500300

inSIGHT Legacy Adaptor Cable
DIVERSATEK HEALTHCARE, INC.
H12R-4500-30
In Commercial Distribution

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system

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
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