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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
ENTROTECH LIFE SCIENCES, LLC
1484CH
In Commercial Distribution

  • B5591484CH00 ()
1484CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 2.375 IN x 2.75 IN, 400 Dressings/Case, 1484CH
ENTROTECH LIFE SCIENCES, LLC
1484BOX
In Commercial Distribution

  • B5591484BOX1 ()
  • B5591484CH0 ()
  • B5591484CASE3 ()
1484BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressing
ENTROTECH LIFE SCIENCES, LLC
1483CH
In Commercial Distribution

  • B5591483CH00 ()
1483CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 1.75 IN x 1.75 IN, 400 Dressings/Case, 1483CH
ENTROTECH LIFE SCIENCES, LLC
1483BOX
In Commercial Distribution

  • B5591483BOX1 ()
  • B5591483CH0 ()
  • B5591483CASE3 ()
1483BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
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
Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC.
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC.
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
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