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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Instrument Max Clinical Refurb
BECTON, DICKINSON AND COMPANY
441927
In Commercial Distribution

  • 00382904419271 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441927

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1011-P
In Commercial Distribution

  • 10816101025036 ()
MOL1011-P

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 288 Molecular System
Neumodx Molecular, Inc.
500100
In Commercial Distribution

  • 00814278020727 ()
  • 10814278020014 ()

  • Depth: 109.2 Centimeter
  • Width: 182.9 Centimeter
  • Height: 190.5 Centimeter
500100

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD COR™ MX
BECTON, DICKINSON AND COMPANY
443989
In Commercial Distribution

  • 00382904439897 ()
443989

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Bd Viper LT System
BECTON, DICKINSON AND COMPANY
442839
In Commercial Distribution

  • 00382904428396 ()

  • Width: 51 Inch
  • Height: 46 Inch
  • Depth: 36 Inch
442839

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Max Clinical
BECTON, DICKINSON AND COMPANY
441916
In Commercial Distribution

  • 00382904419165 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441916

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution

  • 00840733102318 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
This contains the laptop, cube, power adapter and cables.
Genomadix Inc
2
In Commercial Distribution

  • G257ASM000960 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFEOS GENOMICS CORPORATION
md1000 Dx
In Commercial Distribution

  • 04719880531103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
m2000rt Instrument System
ABBOTT MOLECULAR INC.
9K15-01
In Commercial Distribution

  • 00884999031814 ()
9K15-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07402759190
In Commercial Distribution

  • 00875197005660 ()
07402759190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
BIOFIRE DEFENSE, LLC
COMP-SUB-0034
In Commercial Distribution

  • 00851458005297 ()
COMP-SUB-0034

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005129 ()
NGDS-ASY-0002U

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005051 ()
NGDS-ASY-0002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The DASH® Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
Nuclein, LLC
DASH-0002
In Commercial Distribution

  • 00850063063005 ()
SG-0002

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
Fluxergy, Inc.
Mk12.1
In Commercial Distribution

  • 00850027856124 ()
5506-CE

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
OPTOLANE Technologies Inc.
LOAA Analyzer
In Commercial Distribution

  • 08809740940025 ()
LAM301-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-4
In Commercial Distribution

  • 08809537078443 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-3
In Commercial Distribution

  • 08809537078436 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-2
In Commercial Distribution

  • 08809537078429 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-1
In Commercial Distribution

  • 08809537078412 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2061
In Commercial Distribution

  • 08809537070751 ()
A-2061

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2060-1
In Commercial Distribution

  • 08809537070034 ()
A-2060-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
KH Medical Co., Ltd.
KM005
In Commercial Distribution

  • 08800204300690 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products. RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen. Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen.
KH Medical Co., Ltd.
KM002
In Commercial Distribution

  • 08800204300096 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
03531414001
In Commercial Distribution

  • 08430215046203 ()
03531414001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Universal IPPB Circuit
TELEFLEX INCORPORATED
IPN913682
In Commercial Distribution

  • 24026704645767 ()
  • 14026704645760 ()
1560

  • Ventilator breathing circuit, single-use
No Description
DIASORIN SPA
MOL1011
In Commercial Distribution

  • 08056771102889 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN SPA
MOL1001
In Commercial Distribution

  • 08056771102872 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ SDA Extraction Reagent Trough
BECTON, DICKINSON AND COMPANY
441994
In Commercial Distribution

  • 30382904419944 ()
  • 00382904419943 ()
441994

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper Neutralization Pouch
BECTON, DICKINSON AND COMPANY
441354
In Commercial Distribution

  • 30382904413546 ()
  • 00382904413545 ()
441354

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Accessory kit
BECTON, DICKINSON AND COMPANY
442967
In Commercial Distribution

  • 00382904429676 ()
442967

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System SDA Accessory Kit
BECTON, DICKINSON AND COMPANY
442958
In Commercial Distribution

  • 00382904429584 ()
442958

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Tube/Tray Kit
BECTON, DICKINSON AND COMPANY
442957
In Commercial Distribution

  • 00382904429577 ()
442957

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ Extraction Reagent and Lysis Trough
BECTON, DICKINSON AND COMPANY
441128
In Commercial Distribution

  • 00382904411282 ()
441128

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Xiamen Weiyou Intelligent Technology Co.,Ltd
CX5
In Commercial Distribution

  • 06971234470447 ()


  • Circulating-fluid localized thermal therapy system
No Description
ATOM MEDICAL CORPORATION
61633
In Commercial Distribution

  • 04942962616331 ()

  • Depth: 110 Centimeter
  • Width: 84 Centimeter
61633

  • Open infant incubator
BD ProbeTec™ ET Instrument, Remanufactured
BECTON, DICKINSON AND COMPANY
440716
Not in Commercial Distribution

  • 00382904407162 ()

  • Depth: 28.5 Inch
  • Width: 28.5 Inch
  • Height: 21.5 Inch
440716

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
STYLET RFS2-6-12 CLOSURE FAST V02
MEDTRONIC, INC.
RFS2-6-12
In Commercial Distribution

  • 00643169862999 ()

  • Working Length 12 CM
  • Outer Diameter: 2.0 Millimeter
  • Catheter Gauge: 6.0 French


  • Peripheral vascular electrocautery catheter, single-use
No Description
SOMNETICS INTERNATIONAL, INC.
Heated Humidifier
In Commercial Distribution

  • M9505030640 ()

  • Width: 6.625 Inch
  • Length: 12.25 Inch
  • Height: 5.1875 Inch
503064

  • Heated respiratory humidifier
The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without turbulence and create a differential pressure in two points which are connected to differential pressure sensor used to calculate flow. The unique one-way check valve will only allow flow from ventilator to patient and prevent the exhaled flow flowing back to the ventilator. All exhaled flow will be forced out to the atmosphere through the exhausted port of the breathing valve. The 01CV8030 is specifically designed for use with o_two e700, e600 and e500 electronic transport ventilators.
O-Two Medical Technologies Inc
01CV8030
In Commercial Distribution

  • 17540195005331 ()
  • 07540195005334 ()

  • Weight: 260 Gram
  • Length: 6 Feet
01CV8030-CS

  • Ventilator breathing circuit, single-use
HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.
MEDROCK, INC
HR-001
In Commercial Distribution

  • 00860000412711 ()


  • External manual massager, clinical
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
MIGUN LIFE CO., LTD
HY7000UM
In Commercial Distribution

  • B556HY7000UM0 ()


  • Freestanding electric massager
  • Musculoskeletal infrared phototherapy unit, non-wearable
  • Traction table, line-powered
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
KBL GmbH
R11-s-2848r1-1188i1 UP 12
In Commercial Distribution

  • 04260489020425 ()


  • Red/infrared light phototherapy unit
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