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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.
2.X
In Commercial Distribution

  • B553202174RX0 ()


  • 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.
2.X
In Commercial Distribution

  • B553202173OTC0 ()


  • Home pharmaceutical management support software
LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes Rx, which 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. LivingConnected Diabetes and LivingConnected Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. LivingConnected Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.X
In Commercial Distribution

  • B553202143OTC0 ()


  • Home pharmaceutical management support software
LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes Rx, which 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. LivingConnected Diabetes and LivingConnected Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. LivingConnected Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.X
In Commercial Distribution

  • B553202141OTC0 ()


  • Home pharmaceutical management support software
ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25
SKLAR CORPORATION
96-2535A
In Commercial Distribution

  • 50649111488304 ()
  • 10649111488306 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE CEMENT SPATULA #24 STRL CS/25
SKLAR CORPORATION
96-2245M
In Commercial Distribution

  • 50649111448612 ()
  • 10649111448614 ()


  • Orthopaedic cement spatula
ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25
SKLAR CORPORATION
96-2534A
In Commercial Distribution

  • 50649111492653 ()
  • 10649111492655 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25
SKLAR CORPORATION
96-2412A
In Commercial Distribution

  • 50649111487550 ()
  • 10649111487552 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25
SKLAR CORPORATION
96-2534
In Commercial Distribution

  • 50649111478817 ()
  • 10649111478819 ()


  • Dressing/utility forceps, tweezers-like, single-use
ECONO STERILE PROBE W/EYE TRAY CS/50
SKLAR CORPORATION
94-5923
In Commercial Distribution

  • 50649111181663 ()
  • 10649111181665 ()


  • General surgery wound probe/packer
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