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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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SpiroDef (Mouthpiece) with NoseClip
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365500196 ()
  • 07613365500202 ()


  • Pulmonary function testing filter/mouthpiece
SpiroDef ScoutTube
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365500134 ()
  • 07613365500141 ()


  • Pulmonary function testing filter/mouthpiece
SpiroDef Mouthpiece
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365500110 ()
  • 07613365500127 ()


  • Pulmonary function testing filter/mouthpiece
The Noseclip is designed to close the patient's nose during a lung function measurement.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365500103 ()
019410908

  • Nose clip, single-use
The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365500042 ()
013400562

  • Diagnostic spirometer, professional
PIEZON MASTER 700
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002787 ()
FT-194HF

  • Ultrasonic dental scaling/debridement system
PIEZON MASTER 700
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002770 ()
FT-194HF/HF

  • Ultrasonic dental scaling/debridement system
AIR-FLOW MASTER
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002749 ()
FT-185HF/HF

  • Dental abrasive air jet system
AIR-FLOW S1
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353002701 ()
FT-177HF/HF

  • Dental abrasive air jet system
Pulmoguard A and Air Tube Kit
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • B279S29330105001 ()
  • B279S293301050 ()
29-3301-050

  • Pulmonary function testing kit
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