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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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The MediOX is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment.
Braebon Medical Corporation
MD-O
In Commercial Distribution

  • B140MDO0 ()
MD-O

  • Polysomnograph
The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
10028872
In Commercial Distribution

  • 00812101030752 ()
10028872

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-02
In Commercial Distribution

  • 00812101030585 ()
5069-0001-02

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-01
In Commercial Distribution

  • 00812101030578 ()
5069-0001-01

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-00
In Commercial Distribution

  • 00812101030561 ()
5069-0001-00

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
Elvarex Soft 2/Capri-BT-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79457-00007-00
In Commercial Distribution

  • 04019702517880 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/Capri-BT-Body Bandage/with slip form on both sides with adjustable waist band/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79456-00003-00
In Commercial Distribution

  • 04019702517842 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 3/Capri-B1T-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79455-00007-00
In Commercial Distribution

  • 04019702517804 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 2/Capri-B1T-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79454-00007-00
In Commercial Distribution

  • 04019702517767 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/Capri-B1T-Body Bandage/with slip form on both sides with adjustable waist band/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79453-00003-00
In Commercial Distribution

  • 04019702517729 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
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