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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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InfiMed i5, DSA, CCD Camera - 00858086006009

No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose

ID NOW RSV Control Swab Kit - 10811877010538

Control Swabs intended for use only with the ID NOW RSV product.
Alere Scarborough, Inc.
435-080
In Commercial Distribution

  • 10811877010538 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control

ID NOW RSV - 10811877010521

A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Alere i RSV Control Swab Kit - 10811877010132

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

Alere i RSV - 10811877010118

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® - 15420045509320

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

Panther Fusion® - 15420045509290

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)

Rapid Response - 00722066004784

10 Panel One Step DOA Cup (10.11) - COC(300) AMP(1000) MET(1000) THC(50) EDDP(300) MOP(300) OPI(2000) OXY(100) BZO(300) BUP(10)
BTNX Inc
D10.11-1V
In Commercial Distribution

  • 00722066004784 ()


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

HarmonyAIR - 00724995172831

The HarmonyAIR Dual Light with Single Flat Panel Monitor, No 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

  • 00724995172831 ()
LES02NCND

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

HarmonyAIR - 00724995172824

The HarmonyAIR Dual Light with 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

  • 00724995172824 ()
LES02NC02

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

HarmonyAIR - 00724995172817

The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-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

  • 00724995172817 ()
LES02NC01

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

HarmonyAIR - 00724995173562

The HarmonyAIR Single Light 35-inch with Single 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

  • 00724995173562 ()
LES04IN01T

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

HarmonyAIR - 00724995173319

The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, No 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

  • 00724995173319 ()
LES24NCND

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

HarmonyAIR - 00724995173302

The HarmonyAIR Single Light 43-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

  • 00724995173302 ()
LES24NC02

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

HarmonyAIR - 00724995173579

The HarmonyAIR Single 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

  • 00724995173579 ()
LES04IN02T

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

HarmonyAIR - 00724995173548

The HarmonyAIR Single 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

  • 00724995173548 ()
LES04NC02

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

HarmonyAIR - 00724995173531

The HarmonyAIR Single Light 35-inchwith Single Flat Panel Monitor, 13-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

  • 00724995173531 ()
LES04NC01

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

HarmonyAIR - 00724995173401

The HarmonyAIR Single High Definition Light 35-inchwith 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

  • 00724995173401 ()
LEH04INND

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

HarmonyAIR - 00724995173340

The HarmonyAIR Single Light 43-inch with 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

  • 00724995173340 ()
LES24INNDT

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

HarmonyAIR - 00724995173326

The HarmonyAIR Single Light 43-inch with Single 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

  • 00724995173326 ()
LES24IN01T

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