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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BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125
In Commercial Distribution

  • 00850011007068 ()
  • 10850011007065 ()
  • 20850011007062 ()
TNR CDOA6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
963609
In Commercial Distribution

  • 10190302019002 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 1 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56440
In Commercial Distribution

  • 10190302018982 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56519
In Commercial Distribution

  • 10190302019057 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
963608
In Commercial Distribution

  • 10190302019040 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
963613
In Commercial Distribution

  • 10190302019033 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 1 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56441
In Commercial Distribution

  • 10190302019026 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56518
In Commercial Distribution

  • 10190302019019 ()
A56123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 2 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
963612
In Commercial Distribution

  • 10190302018999 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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 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, 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
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
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
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
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
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
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
The Dual Spindle Single Flat Panel Monitor Light Head 11008900 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170417 ()
LG00028

  • Medical monitor/light mount
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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, 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, 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
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
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
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
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
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
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
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
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
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
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
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
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