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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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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
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 3.8 IN x 4.6 IN, 100 Dressings/Case, 1492CH
ENTROTECH LIFE SCIENCES, LLC
1492BOX
In Commercial Distribution

  • B5591492CASE3 ()
  • B5591492BOX1 ()
  • B5591492CH0 ()
1492BOX

  • 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.
v1.0
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
4.0" DIAMETER HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4056
In Commercial Distribution

  • 00888867225381 ()
  • M150ABS40561 ()
  • 10888867225388 ()
ABS-4056

  • Exudate-absorbent dressing, non-gel, antimicrobial
3.0" DIAMETER HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4055
In Commercial Distribution

  • 00888867225374 ()
  • M150ABS40551 ()
  • 10888867225371 ()
ABS-4055

  • Exudate-absorbent dressing, non-gel, antimicrobial
2.5" DIAMETER HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4054
In Commercial Distribution

  • 00888867225367 ()
  • M150ABS40541 ()
  • 10888867225364 ()
ABS-4054

  • Exudate-absorbent dressing, non-gel, antimicrobial
4" X 4" HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4053
In Commercial Distribution

  • 00888867225350 ()
  • M150ABS40531 ()
  • 10888867225357 ()
ABS-4053

  • Exudate-absorbent dressing, non-gel, antimicrobial
4.5" X 10" HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4052
In Commercial Distribution

  • 00888867225343 ()
  • M150ABS40521 ()
  • 10888867225340 ()
ABS-4052

  • Exudate-absorbent dressing, non-gel, antimicrobial
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