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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

E-Scope Hearing Impaired - B37871877100

E-Scope Hearing Impaired
CARDIONICS INC
7187710
In Commercial Distribution

  • B37871877100 ()
718-7710

  • Electronic acoustic stethoscope

E-Scope - B37571877000

Clinical E-Scope
CARDIONICS INC
7187700
In Commercial Distribution

  • B37571877000 ()
718-7700

  • Electronic acoustic stethoscope

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder
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