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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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Aero/Vent Plus w/HEPA Filter & Mask
Medi/Nuclear Corporation, Inc.
AV-400+M
In Commercial Distribution

  • 00857863007222 ()
  • 00857863007055 ()


  • Radioaerosol administration set
Aero/Vent Plus Radioaerosol Unit w/HEPA Filter
Medi/Nuclear Corporation, Inc.
AV-400+
In Commercial Distribution

  • 00857863007215 ()
  • 00857863007048 ()


  • Radioaerosol administration set
Aero/Vent Jr. Ventilator Kit w/HEPA Filter, For ventilator dependent patients
Medi/Nuclear Corporation, Inc.
AV-100HV
In Commercial Distribution

  • 00857863007192 ()
  • 00857863007031 ()


  • Radioaerosol administration set
Aero/Vent Jr. w/HEPA Filter & Mask, Two Tube System
Medi/Nuclear Corporation, Inc.
AV-100HM
In Commercial Distribution

  • 00857863007208 ()
  • 00857863007024 ()


  • Radioaerosol administration set
Aero/Vent Jr. Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, Two Tube System
Medi/Nuclear Corporation, Inc.
AV-100HS
In Commercial Distribution

  • 00857863007185 ()
  • 00857863007017 ()


  • Radioaerosol administration set
Aero/Vent Jr. Radioaerosol Unit w/HEPA Filter, Two Tube System
Medi/Nuclear Corporation, Inc.
AV-100H
In Commercial Distribution

  • 00857863007178 ()
  • 00857863007000 ()


  • Radioaerosol administration set
No Description
Beyond International Inc.
InPulse Touch 100
In Commercial Distribution

  • 00857848007674 ()


  • Dental solid-state laser system
The Spiro PD personal spirometer is a hand held device that is used to test the user’s lung capacity. Measures of air flow and volume are indicators of lung health. By blowing into the tube of the Spiro PD the user can see a measure of his/her forced expiratory volume for one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow from 25% to 75% (FEF 25/75). The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: • 2-12 years - Child • 13-21 years - Adolescent • 22 and over- Adult.
PMD HEALTHCARE, INC.
1.0
In Commercial Distribution

  • 00857845006007 ()
10000101

  • Diagnostic spirometer, professional
Digital Body Fat/Water Scale, Retail Packaging
ESCALI CORP
USHM180G
In Commercial Distribution

  • 00857817000880 ()
  • 00857817000064 ()


  • Bioelectrical body composition analyser
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 6.000
In Commercial Distribution

  • 00857769008019 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
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