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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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Prevahex Antimicrobial Transparent Film Dressing, I.V. Securement
ENTROTECH LIFE SCIENCES, LLC
1488CH
Not in Commercial Distribution

  • B5591488CH00 ()
1488CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN Diameter, 400 Dressings/Case, 1488CH
ENTROTECH LIFE SCIENCES, LLC
1488BOX
Not in Commercial Distribution

  • B5591488BOX1 ()
  • B5591488CH0 ()
  • B5591488CASE3 ()
1488BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Calcium Alginate Silver Dressing
HOLLISTER INCORPORATED
529969R
In Commercial Distribution

  • 20610075029598 ()
  • 10610075029591 ()
  • 30610075029595 ()

  • Length: 46 Centimeter
  • Width: 2.5 Centimeter
529969R

  • Exudate-absorbent dressing, non-gel, antimicrobial
Calcium Alginate Silver Dressing
HOLLISTER INCORPORATED
529968R
In Commercial Distribution

  • 20610075029581 ()
  • 10610075029584 ()
  • 30610075029588 ()

  • Width: 10.2 Centimeter
  • Height: 12 Centimeter
529968R

  • Exudate-absorbent dressing, non-gel, antimicrobial
Calcium Alginate Silver Dressing
HOLLISTER INCORPORATED
529967R
In Commercial Distribution

  • 20610075029574 ()
  • 10610075029577 ()
  • 30610075029571 ()

  • Width: 5 Centimeter
  • Height: 5 Centimeter
529967R

  • Exudate-absorbent dressing, non-gel, antimicrobial
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
PROXIMEL AG DRESSING SM SACRAL 5/BX
HARTMANN USA, INC.
15500000
In Commercial Distribution

  • 20612553023524 ()
  • 10612553023527 ()
  • 30612553023521 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
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