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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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™ 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
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
The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired
PINTLER MEDICAL, LLC
PPWS001
In Commercial Distribution

  • B389PPWS0011 ()
PPWS001

  • External electric-heating core temperature regulation system pad
  • External electric-heating core temperature regulation system control unit
No Description
ICU MEDICAL, INC.
100/199/085
In Commercial Distribution

  • 35019315022351 ()
  • 15019315022357 ()
  • 55019315022355 ()


  • Infant resuscitation cabinet
JBAIDS Instrument
BIOFIRE DEFENSE, LLC
JB01
Not in Commercial Distribution

  • 00851458005006 ()
JRPD-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
1117
In Commercial Distribution

  • 00852588007076 ()
1117

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
6198M
Not in Commercial Distribution

  • 00852588007038 ()
6198M

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
PP1000NS
Not in Commercial Distribution

  • 00852588007021 ()
PP1000NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device
LEXION MEDICAL, LLC
6198NS
Not in Commercial Distribution

  • 00852588007014 ()
6198NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device.
LEXION MEDICAL, LLC
6198
In Commercial Distribution

  • 00852588007007 ()
6198

  • Insufflation gas conditioning tubing set
No Description
BELMONT INSTRUMENT CORPORATION
902-00048
In Commercial Distribution

  • 10896128002579 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00043
Not in Commercial Distribution

  • 10896128002296 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00036
In Commercial Distribution

  • 10896128002289 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00004
Not in Commercial Distribution

  • 10896128002265 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
WRAP, ARTEK PRO-01, UNV COMP01
THERMOTEK, INC.
0P9BATPUNVWRC01
In Commercial Distribution

  • 00850033615050 ()
0P9BATPUNVWRC01

  • Circulating-fluid localized thermal/compression therapy system wrap
Wrap, ArTek Sport,Univ-01,Qty 1
THERMOTEK, INC.
0V9BSPRTUNVWRP01
In Commercial Distribution

  • 00850033615036 ()
0V9BSPRTUNVWRP01

  • Circulating-fluid localized thermal/compression therapy system wrap
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen
Estill Medical Technologies, Inc.
TA-200
In Commercial Distribution

  • 00861816000314 ()
  • 00861816000307 ()
  • 00861816000321 ()


  • Convection blood/fluid warmer
System used to regulate temperature and oxygen content of sterile water for a procedure.
FOCUS SURGERY INC
102-17000-0007
In Commercial Distribution

  • 00868108000274 ()


  • Ultrasonic hyperthermia system
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
FOCUS SURGERY INC
403-02200-0014
In Commercial Distribution

  • 00868108000267 ()


  • Ultrasonic hyperthermia system
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
202-17000-0012
In Commercial Distribution

  • 00868108000229 ()


  • Ultrasonic hyperthermia system
Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
No Description
Azure Biosystems Inc.
Azure Cielo 6 Dx
In Commercial Distribution

  • 00860006465612 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Azure Biosystems Inc.
Azure Cielo 3 Dx
In Commercial Distribution

  • 00860006465605 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
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