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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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HarmonyAIR - 00724995165581

The Touch Panel Control Unit Primary Dual Secondary Single Remote Power Module M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165581 ()
LM0012

  • Medical monitor/light mount

HarmonyAIR - 00724995214326

The E-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214326 ()
LES14NCND

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

HarmonyAIR - 00724995214319

The E-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214319 ()
LES14NC02

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

HarmonyAIR - 00724995214302

The E-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214302 ()
LES14NC01

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

HarmonyAIR - 00724995214173

The E-Series High Density Dual Light, Dual Flat Panel Monitor, No Drop Tube is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214173 ()
LEH14INND

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

HarmonyAIR - 00724995214166

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214166 ()
LEH14IN02

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

HarmonyAIR - 00724995214159

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214159 ()
LEH14IN01

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

HarmonyAIR - 00724995200961

A-Series High Definition 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

  • 00724995200961 ()
LAH14INNDT

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

HarmonyAIR - 00724995200954

A-Series High Definition 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

  • 00724995200954 ()
LAH14IN02T

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

HarmonyAIR - 00724995200947

A-Series High Definition 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

  • 00724995200947 ()
LAH14IN01T

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

HarmonyAIR - 00724995200930

A-Series High Definition 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

  • 00724995200930 ()
LAH14NCND

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

HarmonyAIR - 00724995200923

A-Series High Definition 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

  • 00724995200923 ()
LAH14NC02

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

HarmonyAIR - 00724995200916

A-Series High Definition 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

  • 00724995200916 ()
LAH14NC01

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

HarmonyAIR - 00724995200879

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200879 ()
LAS31NCNDT

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

HarmonyAIR - 00724995200862

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200862 ()
LAS31NC02T

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

HarmonyAIR - 00724995200855

A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200855 ()
LAS31NC01T

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

HarmonyAIR - 00724995170622

The HarmonyAIR E-Series Touch Panel Control Unit with Integrated Power Supplies and Secondary Dual RPM is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170622 ()
LES0012

  • Medical monitor/light mount

HarmonyAIR - 00724995170615

The HarmonyAIR E-Series Touch Panel Control Unit with Integrated Power Supplies and Secondary Single RPM is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170615 ()
LES0011

  • Medical monitor/light mount

HarmonyAIR - 00724995170462

The Dual Spindle Light Head 1750mm Single Flat Panel Monitor 1600mm G-Series 11008905 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
In Commercial Distribution

  • 00724995170462 ()
LK00012

  • Medical monitor/light mount

HarmonyAIR - 00724995170424

The Dual Spindle Single Flat Panel Monitor Light Head with Video 11008901 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170424 ()
LGH00038

  • Medical monitor/light mount

Areta Multi-Drug Test Cup (100 tests kit) - 00855944007581

Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007581 ()
  • 30855944007582 ()
ACDOA-6125B-100

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

Areta Multi-Drug Test Cup (50 tests kit) - 00855944007574

Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007574 ()
  • 30855944007575 ()
ACDOA-6125B-50

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

Areta Multi-Drug Test Cup (10 tests kit) - 00855944007567

Areta 12 Panel Drug Test Cup (10 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007567 ()
  • 30855944007568 ()
ACDOA-6125B-10

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

Areta Multi-Drug Test Cup (25 tests kit) - 00855944007291

Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007298 ()
  • 00855944007291 ()
  • 30855944007292 ()
ACDOA-6125B-25

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

Areta Multi-Drug Test Cup (5 tests kit) - 00855944007284

Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007281 ()
  • 00855944007284 ()
  • 30855944007285 ()
ACDOA-6125B-5

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

VERDICT®-II - 00690286000131

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC) and Cocaine and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601587
Not in Commercial Distribution

  • 00690286000131 ()
  • 10690286000138 ()


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

SELECT TL3 - 05708590372778

SELECT TL3 toilet bracket, for wall outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372778 ()
R9143000

  • Height-adjustable toilet bracket, electric

SELECT TL3 - 05708590372761

SELECT TL3 toilet bracket, for wall outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372761 ()
R9143112

  • Height-adjustable toilet bracket, electric

SELECT TL3 - 05708590372693

SELECT TL3 toilet bracket, for floor outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372693 ()
R9133000

  • Height-adjustable toilet bracket, electric

SELECT TL3 - 05708590372686

SELECT TL3 toilet bracket, for floor outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372686 ()
R9133112

  • Height-adjustable toilet bracket, electric

Ten Panel PreScreen Plus Cup (CLIA Waived) With Alcohol - 00851000007069

Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC With Alcohol
MERGERS MARKETING, INC.
PSC-DOA-4104A
In Commercial Distribution

  • 10851000007073 ()
  • 00851000007076 ()
  • 00851000007069 ()


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

Alpine BioMed - 05704736016810

"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


  • Electromyograph

U-Screen - 00858998006173

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOB
Not in Commercial Distribution

  • 00858998006173 ()
USSCupA-7MOB

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

U-Screen - 00858998006166

U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI2000/AMP/MET/PCP/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-7BP CM
Not in Commercial Distribution

  • 00858998006166 ()
USSCupA-7BP CM

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

MD DrugScreen - 00860001731989

CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731989 ()


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

MD DrugScreen - 00860001731972

CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731972 ()


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

MD DrugScreen - 00860001731965

CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731965 ()


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

VITEK® REVEAL™ SEALER - 00860007326912

The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
BIOMERIEUX , INC.
900-00003
In Commercial Distribution

  • 00860007326912 ()


  • Package sealing unit

HarmonyAIR - 00724995176167

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, No Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176167 ()
LES57NCND

  • Medical monitor/light mount

HarmonyAIR - 00724995176150

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 20-inch Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176150 ()
LES57NC02

  • Medical monitor/light mount
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