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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 - 00724995214296

The E-Series 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

  • 00724995214296 ()
LES14INND

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

HarmonyAIR - 00724995214289

The E-Series 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

  • 00724995214289 ()
LES14IN02

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

HarmonyAIR - 00724995214272

The E-Series 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

  • 00724995214272 ()
LES14IN01

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

Easy@Home 9 Panel Instant Urine Drug Test (25 test kit) - 00855944007413

25 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007413 ()
  • 30855944007414 ()
  • 10855944007410 ()
EDOAP-295-25

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

Easy@Home 9 Panel Instant Urine Drug Test (10 test kit) - 00855944007406

10 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007406 ()
  • 30855944007407 ()
EDOAP-295-10

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

Easy@Home 9 Panel Instant Urine Drug Test (5 test kit) - 00855944007390

5 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007390 ()
  • 30855944007391 ()
EDOAP-295-5

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

Easy@Home 9 Panel Instant Urine Drug Test (2 test kit) - 00855944007383

2 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007383 ()
  • 30855944007384 ()
EDOAP-295-2

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

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane - 00851458005280

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit
BIOFIRE DEFENSE, LLC
DFA2-ASY-0019
In Commercial Distribution

  • 00851458005280 ()
DFA2-ASY-0019

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control

Setmark Incorporated - 00854204008412

Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity
SETMARK INC.
NF-100
In Commercial Distribution

  • 00854204008412 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

MD DrugScreen - 00860003196939

CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)
Medical Disposables Corp
MDC-6125R
In Commercial Distribution

  • 00860003196939 ()


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

MD DrugScreen - 00860003196922

CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)
Medical Disposables Corp
MDC-6125R
In Commercial Distribution

  • 00860003196922 ()


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

MD DrugScreen - 00860003196915

CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)
Medical Disposables Corp
MDC-6125R
In Commercial Distribution

  • 00860003196915 ()


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

HarmonyAIR - 00724995166519

The Single M5 without control with single flat panel monitor and tandem used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166519 ()
LM06NT

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

HarmonyAIR - 00724995192235

The G5 Single Light Hybrid Extension, Camera, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192235 ()
LGH25

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

HarmonyAIR - 00724995191863

The Secondary Spindle Dual/Extension Arm with Dual Flat Panel Monitor is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995191863 ()
LM0032

  • Medical monitor/light mount

HarmonyAIR - 00724995190163

The A-Series Spindle Single Light Single Flat Panel Monitor High Density is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190163 ()
LAH000004

  • Medical monitor/light mount

HarmonyAIR - 00724995190132

The A-Series Spindle Dual Light Single Flat Panel Monitor High Density is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190132 ()
LAH000001

  • Medical monitor/light mount

HarmonyAIR - 00724995170967

The HarmonyAIR E-Series Spindle Single Light 43-inch Dual Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170967 ()
LEH000016

  • Medical monitor/light mount

Rapid Response - 00722066004876

One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1V
In Commercial Distribution

  • 00722066004876 ()


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

HarmonyAIR - 00724995167301

The G5 Dual Light, Camera Ready-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167301 ()
LGH42NT

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

HarmonyAIR - 00724995167264

The G5 Single Camera Ready, Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167264 ()
LGH38NT

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

HarmonyAIR - 00724995167127

The G5 Dual Variable with Camera, No Camera Single Flat Panel is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167127 ()
LGH12N

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

HarmonyAIR - 00724995167110

The G5 Single Light with Camera-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167110 ()
LGH08NT

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

HarmonyAIR - 00724995167080

The G5 Single Adjustable Camera, No Control, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167080 ()
LGH08N

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

HarmonyAIR - 00724995167028

The G5 Dual No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167028 ()
LG41NT

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

HarmonyAIR - 00724995166984

The G5 Single Variable with Single Flat Panel Monitor, Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166984 ()
LG37N

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

HarmonyAIR - 00724995166885

The G5 Dual Fixed with Single Flat Panel Monitor, No Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166885 ()
LG11NFT

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

HarmonyAIR - 00724995166861

The G5 Dual Fixed with Single Flat Panel Monitor, No Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166861 ()
LG11NF

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

HarmonyAIR - 00724995166854

The G5 Dual Adjustable No Camera with Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166854 ()
LG11N

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

HarmonyAIR - 00724995166823

The G5 Single Fixed with Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166823 ()
LG07NFT

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

HarmonyAIR - 00724995166816

The G5 Single Adjustable No Camera-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166816 ()
LG07NT

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

HarmonyAIR - 00724995166809

The G5 Single Fixed-with Single Flat Panel Monitor, No Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166809 ()
LG07NF

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

HarmonyAIR - 00724995166670

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

  • 00724995166670 ()
LGH00034

  • Medical monitor/light mount

HarmonyAIR - 00724995166663

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

  • 00724995166663 ()
LGH00033

  • Medical monitor/light mount

HarmonyAIR - 00724995166021

The Dual Air M7/M5 with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166021 ()
LM08NT

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

HarmonyAIR - 00724995165727

The Dual M5 without Control with Single Flat Panel Monitor, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165727 ()
LM02NT

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

HarmonyAIR - 00724995165710

The Air Single M7 High Density with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165710 ()
LMH09N

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

Six Panel Clear Scan Drug Test Cup with Adulterants - 00851000007328

Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC with Adulterants
MERGERS MARKETING, INC.
CSC-264AD
In Commercial Distribution

  • 00851000007328 ()
  • 00851000007335 ()
  • 10851000007332 ()


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

CSI - 00850798007602

CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-285T
In Commercial Distribution

  • 00850798007626 ()
  • 00850798007619 ()
  • 00850798007602 ()


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

HarmonyAIR - 00724995170974

The HarmonyAIR E-Series Spindle Single Light 35.5-inch Dual Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170974 ()
LEH000017

  • Medical monitor/light mount
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