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 HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172893 ()
LES02NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172879 ()
LES02NC01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light 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

  • 00724995172688 ()
LEH02INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light 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

  • 00724995172671 ()
LEH02IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light 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

  • 00724995172664 ()
LEH02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
RANDOX LABORATORIES LIMITED
EV3550
In Commercial Distribution

  • 05055273202458 ()
EV3550

  • Multiple drugs of abuse IVD, calibrator
UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI300/OXY/THC/BUP with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-DUD-7104-RCN
In Commercial Distribution

  • 20817038021921 ()
  • 10817038021924 ()
  • 00817038021927 ()
U-DUD-7104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/AMP/BUP with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-DUD-7104-RCN
In Commercial Distribution

  • 20817038021808 ()
  • 10817038021801 ()
  • 00817038021804 ()
U-DUD-7104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
TDOA-XC10A
In Commercial Distribution

  • 00817405021383 ()
  • 10817405021380 ()
TDOA-XC10A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(Identify USA - Drug Test Cups) / 12 Panel CLIA Waived Cup - AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, MOR/OPI300, OXY100, PCP25, THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US12-BUP
In Commercial Distribution

  • 20850721007932 ()
  • 10850721007935 ()
  • 00850721007938 ()
ID-US12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12CLIA
Not in Commercial Distribution

USSCUPA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-12BUP300CLIA
In Commercial Distribution

USSCUPA-12BUP30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)
Instant Technologies, Inc.
I-DXP-2107-01
In Commercial Distribution

  • 00817405020355 ()
I-DXP-2107-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.13
In Commercial Distribution

  • 00850009343130 ()


  • Radiological PACS software
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.12
Not in Commercial Distribution

  • 00850009343031 ()


  • Radiological PACS software
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605105
Not in Commercial Distribution

  • 00690286000469 ()
  • 10690286000466 ()


  • 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, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605100
In Commercial Distribution

  • 10690286000411 ()
  • 00690286000414 ()


  • 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, Tricyclic Antidepressants, Barbiturates, Methadone, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601591
In Commercial Distribution

  • 10690286000275 ()
  • 00690286000278 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready, Single Cardanic with Tandem and Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192426 ()
LGH42T

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The HarmonyAIR Single High Definition Light 35-inch 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

  • 00724995173456 ()
LEH04IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173425 ()
LEH04NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173357 ()
LES24NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, and Barbiturates drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604019
In Commercial Distribution

  • 10690286000022 ()
  • 00690286000025 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Hybrid High Definition 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

  • 00724995176099 ()
LEH56IN02T

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

  • 00724995176013 ()
LES56NCNDT

  • 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, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175993 ()
LES56NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition 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

  • 00724995175740 ()
LEH13INNDT

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