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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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Airlife™ Isothermal™ Breaathing Circuit Adult Respiratory Circuit Heated
Carefusion Corporation
6463-H08
Not in Commercial Distribution

  • 50885403027022 ()
  • 10885403027024 ()
6463-H08

  • Non-heated respiratory humidifier
  • Airway pressure monitor, non-powered
  • Ventilator breathing circuit, single-use
  • Inspiratory/expiratory limb respiratory tubing, reusable
Lap-port closure device guides 5mm and 10/12 mm Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGR510/12
In Commercial Distribution

  • B354OSLPCDGR510120 ()
OSLPCDGR

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap-port closure device guides 10/12mm and 15 mm Bariatric Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGBR
In Commercial Distribution

  • B354OSLPCDGBR0 ()
OSLPCDGBR

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.
TECO DIAGNOSTICS
TC-Matrix-480
In Commercial Distribution

  • 10673486013962 ()
TC-Matrix-480

  • Multiple clinical chemistry analyser IVD, laboratory
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.
TECO DIAGNOSTICS
TC-Matrix-240
In Commercial Distribution

  • 10673486013894 ()
TC-Matrix-240

  • Multiple clinical chemistry analyser IVD, laboratory
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.
TECO DIAGNOSTICS
TC-MATRIX-160
In Commercial Distribution

  • 10673486013726 ()
TC-MATRIX-160

  • Multiple clinical chemistry analyser IVD, laboratory
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.
TECO DIAGNOSTICS
TC-Matrix
In Commercial Distribution

  • 10673486013580 ()
TC-Matrix

  • Multiple clinical chemistry analyser IVD, laboratory
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
Carefusion Corporation
7102-HS7
Not in Commercial Distribution

  • 50885403027114 ()
  • 10885403027116 ()
7102-HS7

  • Airway pressure monitor, non-powered
  • Ventilator breathing circuit, single-use
  • Straight/elbow breathing circuit connector, single-use
  • Non-heated respiratory humidifier
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
Carefusion Corporation
9037-HS7
Not in Commercial Distribution

  • 50885403027312 ()
  • 10885403027314 ()
9037-HS7

  • Ventilator breathing circuit, single-use
  • Non-heated respiratory humidifier
  • Metered dose inhaler
  • Airway pressure monitor, non-powered
The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution

  • B357AMI1001 ()


  • Electrocautery system, line-powered
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