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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Calcium chloride additive for bicarbonate dialysis.
Di-Chem, Incorporated
BAC-02
In Commercial Distribution

  • B637BAC021 ()
  • B637BAC020 ()


  • Haemodialysis concentrate
Calcium chloride additive for bicarbonate dialysis.
Di-Chem, Incorporated
BAC-01
In Commercial Distribution

  • B637BAC011 ()
  • B637BAC010 ()


  • Haemodialysis concentrate
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403520RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403515RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403510RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403020RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403015RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141403010RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141402520RX1 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CX141402515RX1 ()


  • Coronary angioplasty balloon catheter, basic
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