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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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Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / COC / M-AMP / THC
RAPID DIAGNOSTICS INC
07RD7064-38
In Commercial Distribution

  • 00817830021682 ()

  • Length: 75 Millimeter
07RD7064-38

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-37
In Commercial Distribution

  • 00817830021675 ()

  • Length: 75 Millimeter
07RD7064-37

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7064-36
In Commercial Distribution

  • 00817830021668 ()

  • Length: 75 Millimeter
07RD7064-36

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-35
In Commercial Distribution

  • 00817830021651 ()

  • Length: 75 Millimeter
07RD7064-35

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI-II/ OXY
RAPID DIAGNOSTICS INC
07RD7064-34A
In Commercial Distribution

  • 00817830021644 ()

  • Length: 75 Millimeter
07RD7064-34A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7064-34
In Commercial Distribution

  • 00817830021637 ()

  • Length: 75 Millimeter
07RD7064-34

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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