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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI-2000 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-03A
In Commercial Distribution

  • M90107RD706403A0 ()
  • M90107RD706403A1 ()

  • Length: 75 Millimeter
07RD7064-03A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-03
In Commercial Distribution

  • M90107RD7064031 ()
  • M90107RD7064030 ()

  • Length: 75 Millimeter
07RD7064-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-02
In Commercial Distribution

  • M90107RD7064021 ()
  • M90107RD7064020 ()

  • Length: 75 Millimeter
07RD7064-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-01
In Commercial Distribution

  • M90107RD7064011 ()
  • M90107RD7064010 ()

  • Length: 75 Millimeter
07RD7064-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-28
In Commercial Distribution

  • M90107RD7063280 ()
  • M90107RD7063281 ()

  • Length: 75 Millimeter
07RD7063-28

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-03
In Commercial Distribution

  • M90107RD7063031 ()
  • M90107RD7063030 ()

  • Length: 75 Millimeter
07RD7063-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-04
In Commercial Distribution

  • M90107RD7062041 ()
  • M90107RD7062040 ()

  • Length: 75 Millimeter
07RD7062-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-04A
In Commercial Distribution

  • M90107RD706104A1 ()
  • M90107RD706104A0 ()

  • Length: 75 Millimeter
07RD7061-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-02A
In Commercial Distribution

  • M90107RD706102A1 ()
  • M90107RD706102A0 ()

  • Length: 75 Millimeter
07RD7061-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Optional Power Down Foot Platform Module (Lower Assy) designed for use wit the Power Elevating Calf Panel Assy. (Foot Platform sold separately). Assembly includes actuator motor. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0229-PEACPDF
In Commercial Distribution

  • 07540147002466 ()
PEACPDF

  • Wheelchair footrest/legrest
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
ADVIN BIOTECH, INC.
PPCup-14-01
In Commercial Distribution

  • 00840050517536 ()
  • 10840050517533 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
ADVIN BIOTECH, INC.
PPCup-12-71
In Commercial Distribution

  • 10840050517526 ()
  • 00840050517529 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI300/THC50
ADVIN BIOTECH, INC.
PPCup-06-67
In Commercial Distribution

  • 10840050517519 ()
  • 00840050517512 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
ADVIN BIOTECH, INC.
PPCup-12-02
In Commercial Distribution

  • 10840050517496 ()
  • 00840050517499 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accessory device that mounts to the source side of a 21cm GE OEC Elite CFD.
TrackX Technology, LLC
21 cm Flat Panel Cap Assembly
In Commercial Distribution

  • 00857088008486 ()


  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 21cm GE OEC Elite CFD.
TrackX Technology, LLC
21 cm Flat Panel Collar Assembly
In Commercial Distribution

  • 00857088008479 ()


  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 31cm GE OEC Elite CFD.
TrackX Technology, LLC
31 cm Flat Panel Cap Assembly
In Commercial Distribution

  • 00857088008462 ()


  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
TrackX Technology, LLC
31 cm Flat Panel Collar Assembly
In Commercial Distribution

  • 00857088008455 ()


  • Diagnostic x-ray digital imaging system workstation application software
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT CERTUS SIDE PANEL SLATE, SOFHYDE
In Commercial Distribution

  • 00045915829858 ()
100-CERTUS-005S

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT CERTUS SIDE PANEL MOON, SOFHYDE
In Commercial Distribution

  • 00045915829841 ()
100-CERTUS-004S

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT CERTUS SIDE PANEL SKY, SOFHYDE
In Commercial Distribution

  • 00045915829834 ()
100-CERTUS-003S

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT CERTUS SIDE PANEL SUN, SOFHYDE
In Commercial Distribution

  • 00045915829827 ()
100-CERTUS-002S

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT CERTUS SIDE PANEL EARTH, SOFHYDE
In Commercial Distribution

  • 00045915829810 ()
100-CERTUS-001S

  • Bed/chair electric massager
No Description
LivaNova Deutschland GmbH
Pump Control Panel for S5/C5
In Commercial Distribution

  • 04033817900993 ()


  • Cardiopulmonary bypass system, roller type
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Tech Subsidiary Acquisition
USSCupA-5M
Not in Commercial Distribution

  • 00858998006142 ()
USSCupA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Tech Subsidiary Acquisition
USSCup-10M
Not in Commercial Distribution

  • 00858998006012 ()
USSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 12 Panel (PPX) BZO300/BAR300/COC150/THC50/MET500/OPI2000/ MTD300/OXY100/MDMA500/PCP25/AMP500/PPX300
NEXSCREEN, LLC
NCard-12-PPX
In Commercial Distribution

  • 00858984006323 ()
NCard-12-PPX

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HarmonyAIR A-Series High Density Dual Adjustable Light, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203078 ()
LAH02A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201050 ()
LAS14NCND

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
A-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201043 ()
LAS14NC02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201036 ()
LAS14NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201081 ()
LAS14INNDT

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201074 ()
LAS14IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201067 ()
LAS14IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
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