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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Control Swabs intended for use only with the Alere i RSV product.
Alere Scarborough, Inc.
435-080
Not in Commercial Distribution

  • 10811877010132 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
Not in Commercial Distribution

  • 10811877010118 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® AdV/hMPV/RV Controls Kit.
Hologic, Inc.
AMR CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509320 ()
PRD-04338

  • Multiple-genus respiratory virus nucleic acid IVD, control
The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).
Hologic, Inc.
AMR KIT, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509290 ()
PRD-04330

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
SELECT TL4 toilet bracket, for wall outlet, prepared for shower toilet seat, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9144
In Commercial Distribution

  • 05708590372938 ()
R9144000

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for wall outlet, prepared for shower toilet seat, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9144
In Commercial Distribution

  • 05708590372921 ()
R9144112

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9134
In Commercial Distribution

  • 05708590372853 ()
R9134000

  • Height-adjustable toilet bracket, electric
SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9134
In Commercial Distribution

  • 05708590372846 ()
R9134112

  • Height-adjustable toilet bracket, electric
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605201
In Commercial Distribution

  • 00690286000490 ()
  • 10690286000497 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Amphetamine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605101
In Commercial Distribution

  • 10690286000428 ()
  • 00690286000421 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Phencyclidine, and THC (cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600715
Not in Commercial Distribution

  • 00690286000391 ()
  • 10690286000398 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates and Benzodiazepines and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601660
In Commercial Distribution

  • 00690286000353 ()
  • 10690286000350 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601607
In Commercial Distribution

  • 00690286000339 ()
  • 10690286000336 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601645
Not in Commercial Distribution

  • 10690286000251 ()
  • 00690286000254 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601639
Not in Commercial Distribution

  • 10690286000220 ()
  • 00690286000223 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Barbiturates, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601622
In Commercial Distribution

  • 10690286000176 ()
  • 00690286000179 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, and Barbiturates drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604020
In Commercial Distribution

  • 10690286000039 ()
  • 00690286000032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
  • Multiplex analyser IVD, laboratory
U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-12BUP300
Not in Commercial Distribution

  • 00858998006104 ()
USSCupA-12BUP300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 12 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BZO/BUP/MDMA/MTD/OXY/PPX)
Instant Tech Subsidiary Acquisition
USSCupA-12
Not in Commercial Distribution

  • 00858998006098 ()
USSCupA-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-10MOB-300CLIA
Not in Commercial Distribution

  • 00858998006081 ()
USSCupA-10MOB-300CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172855 ()
LES02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173333 ()
LES24IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173289 ()
LES24INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173265 ()
LES24IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
"Keypoint Focus Notebook System, FRA Including: - Notebook PC with Keypoint software, MS Office - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071102
Not in Commercial Distribution

  • 05704736017138 ()


  • Electromyograph
"Keypoint Focus Notebook System, Intl. 230V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071101
Not in Commercial Distribution

  • 05704736017121 ()


  • Electromyograph
"Keypoint Focus Notebook System, Intl. 115V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711HA
Not in Commercial Distribution

  • 05704736017114 ()


  • Electromyograph
Status Toxi-Cup 13 panel drug cup with 4 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000 BUP10 Adulterants - CRE, pH, SG, NBP
Lifesign L.L.C.
65C12+4
Not in Commercial Distribution

  • 20863480002117 ()
  • 10863480002110 ()
  • 00863480002113 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175924 ()
LES56INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175917 ()
LES56IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175900 ()
LES56IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175863 ()
LES13INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175856 ()
LES13IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175849 ()
LES13IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175627 ()
LES11INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175610 ()
LES11IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175603 ()
LES11IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173586 ()
LES04INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173524 ()
LES04INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 35-inch with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173517 ()
LES04IN02

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