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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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Diversatek Healthcare - 00816734021897

Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3152
In Commercial Distribution

  • 00816734021897 ()
  • B019D8231520 ()
D82-3152

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021880

Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3151
In Commercial Distribution

  • 00816734021880 ()
  • B019D8231510 ()
D82-3151

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021873

Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3103
In Commercial Distribution

  • 00816734021873 ()
  • B019D8231030 ()
D82-3103

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021866

Motility Cart for inSIGHT Ultima® and PriZm Motility Systems
DIVERSATEK HEALTHCARE, INC.
CART5R
In Commercial Distribution

  • 00816734021866 ()
  • B019CART5R0 ()
CART5R

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021835

Anorectal Balloon, 400CC TPE
DIVERSATEK HEALTHCARE, INC.
A86-4300-10
In Commercial Distribution

  • 10816734021832 ()
  • 00816734021835 ()
  • B019A864300100 ()
A86-4300-10

  • Manometric gastrointestinal motility analysis system

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 - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder
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