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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Siemens INTUIS 2 Hearing Aid
Ws Audiology Usa, Inc.
INTUIS 2
Not in Commercial Distribution

  • 04056839060490 ()
10932963

  • Air-conduction hearing aid, in-the-ear
Siemens SIRION 2 Hearing Aid
Ws Audiology Usa, Inc.
SIRION 2
Not in Commercial Distribution

  • 04056839060483 ()
10932961

  • Air-conduction hearing aid, in-the-ear
Siemens ORION 2 Hearing Aid
Ws Audiology Usa, Inc.
ORION 2
Not in Commercial Distribution

  • 04056839060476 ()
10932959

  • Air-conduction hearing aid, in-the-ear
Siemens UNITY 3 REF MIC (REFURBISHED)
Ws Audiology Usa, Inc.
UNITY 3 REF MIC (REFURBISHED)
Not in Commercial Distribution

  • 04056839030059 ()
10933235

  • Audiometric/hearing aid tester
Siemens UNITY 3 COUPLER (REFURBISHED)
Ws Audiology Usa, Inc.
UNITY 3 COUPLER (REFURBISHED)
Not in Commercial Distribution

  • 04056839030042 ()
10933234

  • Audiometric/hearing aid tester
Siemens UNITY 3 B71 (REFURBISHED)
Ws Audiology Usa, Inc.
UNITY 3 B71 (REFURBISHED)
Not in Commercial Distribution

  • 04056839030035 ()
10933232

  • Audiometric/hearing aid tester
DM/VS Lipase Calibrator
Siemens Healthcare Diagnostics Inc.
10735073
Not in Commercial Distribution

  • 00842768026904 ()
DC56A

  • Lipase IVD, calibrator
Siemens HA SIRION 2 SP GR Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP GR
Not in Commercial Distribution

  • 04038953854131 ()
10937281

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP DEMO BG Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP DEMO BG
Not in Commercial Distribution

  • 04038953854124 ()
10940187

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP DBR Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP DBR
Not in Commercial Distribution

  • 04038953854117 ()
10937280

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP BG Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP BG
Not in Commercial Distribution

  • 04038953854100 ()
10937279

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP GR Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP GR
Not in Commercial Distribution

  • 04038953854025 ()
10937284

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP DEMO BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP DEMO BG
Not in Commercial Distribution

  • 04038953854018 ()
10940188

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP DBR Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP DBR
Not in Commercial Distribution

  • 04038953854001 ()
10937283

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP BG
Not in Commercial Distribution

  • 04038953853998 ()
10937282

  • Air-conduction hearing aid, behind-the-ear
Siemens ECHARGER 13-M U.S. NTS. Hearing aid accessory.
Ws Audiology Usa, Inc.
ECHARGER 13-M U.S. NTS
Not in Commercial Distribution

  • 04038953848833 ()
10827876

  • Air-conduction hearing aid, behind-the-ear
Siemens CHARGER 312-L U.S NTS. Hearing aid accessory.
Ws Audiology Usa, Inc.
CHARGER 312-L U.S NTS
Not in Commercial Distribution

  • 04038953848802 ()
10822081

  • Air-conduction hearing aid, behind-the-ear
Description: 28% CO2, 1.4% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration Gas
In Commercial Distribution

  • 00819601020214 ()

  • Total Volume: 7500 Liter
  • Pressure: 1930 Pound per Square Inch
Z03NI70J3000000

  • Calibration gas/refillable cylinder
Description: 4.5% CO2, 19.5% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022737 ()

  • Total Volume: 8000 Liter
  • Pressure: 2400 Pound per Square Inch
Z03NI768300C000

  • Calibration gas/refillable cylinder
Description: 0.75% CO2, 2.1% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022362 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8000 Liter
Z03NI97M3000006

  • Multiple blood gas analyte IVD, calibrator
Description: 2% CO2, 12% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022355 ()

  • Pressure: 2400 Pound per Square Inch
Z03NI868300C001

  • Multiple blood gas analyte IVD, calibrator
Description: 1% CO2, 1% O2, Bal. N2, P.G.S.; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022256 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8000 Liter
Z03NI98M3000003

  • Multiple blood gas analyte IVD, calibrator
Description: 99.999% Carbon Monoxide; Cylinder: CL; Valve: CGA 350; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022249 ()

  • Pressure: 2000 Pound per Square Inch
  • Total Volume: 800 Liter
CM MDG33A

  • Multiple blood gas analyte IVD, calibrator
Description 99.99% Nitrogen; Cylinder: K; Valve: CGA 580; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022232 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8000 Liter
NI UHP300C365

  • Multiple blood gas analyte IVD, calibrator
Description: 17% CO2, 18% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022126 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8854 Liter
Z03NI658300C002

  • Multiple blood gas analyte IVD, calibrator
Description: 1.5% O2, Bal. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022119 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8000 Liter
Z02NI9883000008

  • Multiple blood gas analyte IVD, calibrator
Description: 20% CO2, 15% O2, Bal. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022102 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8985 Liter
Z03NI658300C001

  • Multiple blood gas analyte IVD, calibrator
Description: 20% N2O, 15% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration gas
In Commercial Distribution

  • 00819601022041 ()

  • Pressure: 2200 Pound per Square Inch
  • Total Volume: 8820 Liter
Z03NI65M3000002

  • Multiple blood gas analyte IVD, calibrator
Description: 2% CO2, BAL. O2 - PGS; Cylinder: K; Valve: CGA 296; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration gas
In Commercial Distribution

  • 00819601022034 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 8771 Liter
Z02OX98M3000000

  • Multiple blood gas analyte IVD, calibrator
Description: 17% N2O, 18% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration gas
In Commercial Distribution

  • 00819601022027 ()

  • Pressure: 2400 Pound per Square Inch
  • Total Volume: 9484 Liter
Z03NI65M3000001

  • Multiple blood gas analyte IVD, calibrator
Description: 4.9% CO2, 7.7% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration Gas
In Commercial Distribution

  • 00819601020979 ()

  • Total Volume: 8000 Liter
  • Pressure: 2400 Pound per Square Inch
Z03NI87J3000001

  • Calibration gas/refillable cylinder
Description: 6.3% CO2, 28% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration Gas
In Commercial Distribution

  • 00819601020962 ()

  • Total Volume: 8000 Liter
  • Pressure: 2400 Pound per Square Inch
Z03NI65J3000000

  • Calibration gas/refillable cylinder
Description: 0.7% CO2, 98.2% O2, BAL. N2 - PGS; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
Airgas Therapeutics, LLC
Calibration Gas
In Commercial Distribution

  • 00819601020955 ()

  • Total Volume: 8000 Liter
  • Pressure: 2200 Pound per Square Inch
Z03NI1J3000000

  • Calibration gas/refillable cylinder
Siemens HA INTUIS LIFE BLK Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS LIFE BLK
Not in Commercial Distribution

  • 04025515218708 ()
10172228

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS LIFE GNT Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS LIFE GNT
Not in Commercial Distribution

  • 04025515218692 ()
10172226

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS LIFE BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS LIFE BG
Not in Commercial Distribution

  • 04025515218685 ()
10147422

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS SP DIR BLK Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS SP DIR BLK
Not in Commercial Distribution

  • 04025515218531 ()
10172065

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS SP DIR GNT Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS SP DIR GNT
Not in Commercial Distribution

  • 04025515218524 ()
10172063

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS SP DIR BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS SP DIR BG
Not in Commercial Distribution

  • 04025515218517 ()
10147385

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS DIR BLK Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS DIR BLK
Not in Commercial Distribution

  • 04025515218500 ()
10172173

  • Air-conduction hearing aid, behind-the-ear
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