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 SET CROS PURE BG Hearing Aid
Ws Audiology Usa, Inc.
SET CROS PURE BG
Not in Commercial Distribution

  • 04056839063729 ()
10934252

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

  • 04056839062562 ()
10935161

  • Air-conduction hearing aid, behind-the-ear
Siemens BTE ORION 2 RIC312 DEMO BG Hearing Aid
Ws Audiology Usa, Inc.
BTE ORION 2 RIC312 DEMO BG
Not in Commercial Distribution

  • 04056839062555 ()
10935167

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

  • 04056839062548 ()
10935165

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

  • 04056839062531 ()
10935163

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SA 7BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SA 7BX PRL
Not in Commercial Distribution

  • 04056839060582 ()
10933340

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SA 5BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SA 5BX PRL
Not in Commercial Distribution

  • 04056839060575 ()
10933339

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SA 3BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SA 3BX PRL
Not in Commercial Distribution

  • 04056839060568 ()
10933338

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SX 7BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SX 7BX PRL
Not in Commercial Distribution

  • 04056839060551 ()
10933337

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SX 5BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SX 5BX PRL
Not in Commercial Distribution

  • 04056839060544 ()
10933336

  • Air-conduction hearing aid, behind-the-ear
Siemens HA MOTION SX 3BX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MOTION SX 3BX PRL
Not in Commercial Distribution

  • 04056839060537 ()
10933335

  • Air-conduction hearing aid, behind-the-ear
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 COUP. MIC RECD AIR-FAT
Ws Audiology Usa, Inc.
Unity 3 COUP. MIC RECD AIR-FAT
Not in Commercial Distribution

  • 05711781001371 ()
10940054

  • Audiometric/hearing aid tester
Siemens UNITY 3 REF MIC RECD AIR-FAT
Ws Audiology Usa, Inc.
UNITY 3 REF MIC RECD AIR-FAT
Not in Commercial Distribution

  • 05711781001357 ()
10940055

  • Audiometric/hearing aid tester
Siemens UNITY 3 HIGH FREQUENCY
Ws Audiology Usa, Inc.
UNITY 3 HIGH FREQUENCY
Not in Commercial Distribution

  • 05711781000770 ()
10824334

  • Audiometric/hearing aid tester
Siemens UNITY 3 STANDARD WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 STANDARD WITH INSERTS
Not in Commercial Distribution

  • 05711781000756 ()
10824332

  • Audiometric/hearing aid tester
Siemens UNITY 3 HIT UNIT PACKAGE
Ws Audiology Usa, Inc.
UNITY 3 HIT UNIT PACKAGE
Not in Commercial Distribution

  • 05711781000657 ()
10823932

  • Audiometric/hearing aid tester
Siemens UNITY 3 FITTING UNIT
Ws Audiology Usa, Inc.
UNITY 3 FITTING UNIT
Not in Commercial Distribution

  • 05711781000640 ()
10824090

  • Audiometric/hearing aid tester
Siemens Unity 3 Fitting Unit - Package
Ws Audiology Usa, Inc.
Unity 3 Fitting Unit - Package
Not in Commercial Distribution

  • 05711781000633 ()
10823931

  • Audiometric/hearing aid tester
Siemens UNITY 3 REFERENCE MICROPHONE
Ws Audiology Usa, Inc.
UNITY 3 REFERENCE MICROPHONE
Not in Commercial Distribution

  • 05711781000374 ()
10823952

  • Audiometric/hearing aid tester
Siemens UNITY 3 3A INSERTS
Ws Audiology Usa, Inc.
UNITY 3 3A INSERTS
Not in Commercial Distribution

  • 05711781000121 ()
10823934

  • Audiometric/hearing aid tester
Siemens UNITY 3 DD45
Ws Audiology Usa, Inc.
UNITY 3 DD45
Not in Commercial Distribution

  • 05711781000107 ()
10823935

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

  • 05711781000084 ()
10823938

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

  • 05711781000053 ()
10933231

  • Audiometric/hearing aid tester
Siemens UNITY 3 REM PROBE ASSEMBLY
Ws Audiology Usa, Inc.
UNITY 3 ITE FOAM
Not in Commercial Distribution

  • 05711781000046 ()
10823933

  • Audiometric/hearing aid tester
Real-Ear Inserts
Ws Audiology Usa, Inc.
UNITY 3 BTE TUBE
Not in Commercial Distribution

  • 05711781000039 ()
10823936

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

  • 05711781000008 ()
10823938

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

  • 05711781000954 ()
10823951

  • Audiometric/hearing aid tester
Siemens UNITY 3 HDA300 HEADSET
Ws Audiology Usa, Inc.
UNITY 3 HDA300 HEADSET
Not in Commercial Distribution

  • 05711781000800 ()
10825966

  • Audiometric/hearing aid tester
Siemens UNITY 3 REAL EAR FULL PACKAGE
Ws Audiology Usa, Inc.
UNITY 3 REAL EAR FULL PACKAGE
Not in Commercial Distribution

  • 05711781000787 ()
10824335

  • Audiometric/hearing aid tester
Siemens UNITY 3 CLINICAL
Ws Audiology Usa, Inc.
UNITY 3 CLINICAL
Not in Commercial Distribution

  • 05711781000763 ()
10824333

  • Audiometric/hearing aid tester
Siemens UNITY 3 WITH INSERT
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERT
Not in Commercial Distribution

  • 05711781000749 ()
10824331

  • Audiometric/hearing aid tester
Siemens UNITY 3 STANDARD
Ws Audiology Usa, Inc.
UNITY 3 STANDARD
Not in Commercial Distribution

  • 05711781000732 ()
10824330

  • Audiometric/hearing aid tester
Siemens UNITY 3 HIT UNIT
Ws Audiology Usa, Inc.
UNITY 3 HIT UNIT
Not in Commercial Distribution

  • 05711781000664 ()
10824092

  • Audiometric/hearing aid tester
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
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
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