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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Thermistor Airflow Ped
Ambu A/S
1420402
Not in Commercial Distribution

  • 05707480043118 ()
1420402

  • Polysomnograph
CareFusion Kit, z4 Lead
Ambu A/S
11626
Not in Commercial Distribution

  • 05707480043101 ()
11626

  • Polysomnograph
Breathoprene Ankle Band (Pair)
Ambu A/S
817000-000
In Commercial Distribution

  • 05707480042876 ()
817000-000

  • Polysomnograph
Limb Sensor Kit (one limb) Min. purchase is 5 pcs. = 1 set (Sleepmate item 1711)
Ambu A/S
817210-100
In Commercial Distribution

  • 05707480042852 ()
  • 05707480096800 ()
817210-100

  • Polysomnograph
Multi UARS/Airflow Cable
Ambu A/S
814400-100
In Commercial Distribution

  • 05707480042395 ()
814400-100

  • Polysomnograph
Ref. 14878
Ambu A/S
814360-000/25
In Commercial Distribution

  • 05707480041886 ()
  • 05707480134007 ()
814360-000/25

  • Polysomnograph
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034114-00
In Commercial Distribution

  • 06936415912604 ()


  • Carbon dioxide sensor/cable
DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603775
Not in Commercial Distribution

  • 10816843021440 ()
  • 10816843021457 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: SMALL, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603706
Not in Commercial Distribution

  • 10816843021426 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603700
Not in Commercial Distribution

  • 10816843021402 ()


  • Patient monitoring system module, electrocardiographic/respiratory
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