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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Airflow Thermistor 1.5 mm
Ambu A/S
1420431
Not in Commercial Distribution

  • 05707480043149 ()
1420431

  • Polysomnograph
Airflow Thermistor
Ambu A/S
1420430
Not in Commercial Distribution

  • 05707480043125 ()
1420430

  • Polysomnograph
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
Ref. 1770
Ambu A/S
817230-100
In Commercial Distribution

  • 05707480042890 ()
  • 05707480096800 ()
817230-100

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

  • 05707480042876 ()
817000-000

  • Polysomnograph
Ref. 1715 (two limbs)
Ambu A/S
817220-100
In Commercial Distribution

  • 05707480042869 ()
  • 05707480096800 ()
817220-100

  • 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
Ref. 1261
Ambu A/S
812500-020
In Commercial Distribution

  • 05707480042463 ()
  • 05707480096480 ()
812500-020

  • Polysomnograph
Sleepmate Item 1258
Ambu A/S
812500-019
In Commercial Distribution

  • 05707480042456 ()
  • 05707480096473 ()
812500-019

  • Polysomnograph
Snoring Piezo Sensor (Sleepmate item 1250)
Ambu A/S
812200-000
In Commercial Distribution

  • 05707480042425 ()
  • 05707480096466 ()
812200-000

  • Polysomnograph
Microphone
Ambu A/S
812500-000
In Commercial Distribution

  • 05707480042418 ()
812500-000

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

  • 05707480042395 ()
814400-100

  • Polysomnograph
Sensors, Small/Infant. Pack of 20 pcs. (Sleepmate item 1428)
Ambu A/S
814301-000/20
In Commercial Distribution

  • 05707480042364 ()
  • 05707480133949 ()

  • Infant
814301-000/20

  • Polysomnograph
Sensors, 20-Pack, Medium/Pediatric (Sleepmate item 1427)
Ambu A/S
814302-000/20
In Commercial Distribution

  • 05707480042357 ()
  • 05707480133956 ()

  • Pediatric
814302-000/20

  • Polysomnograph
Ref. 1426
Ambu A/S
814303-000/20
In Commercial Distribution

  • 05707480042340 ()
  • 05707480133963 ()

  • Adult
814303-000/20

  • Polysomnograph
CannuTherm Thermistor Kit
Ambu A/S
814930-100
In Commercial Distribution

  • 05707480042258 ()

  • Size 2
814930-100

  • Polysomnograph
Nasal Cannula W/filter
Ambu A/S
814310-071
In Commercial Distribution

  • 05707480042241 ()
  • 05707480133987 ()

  • Adult
814310-071

  • Polysomnograph
Alice 5 Thermistor
Ambu A/S
814910-121
In Commercial Distribution

  • 05707480042180 ()
814910-121

  • Polysomnograph
Alice 3 Thermistor
Ambu A/S
814910-119
In Commercial Distribution

  • 05707480042135 ()
814910-119

  • Polysomnograph
Cannutherm Thermistor
Ambu A/S
814960-100
In Commercial Distribution

  • 05707480042111 ()
814960-100

  • Polysomnograph
Ref. 1457
Ambu A/S
814900-125
Not in Commercial Distribution

  • 05707480042104 ()
  • 05707480097043 ()
814900-125

  • Polysomnograph
Thermistor Airflow Sensor
Ambu A/S
814940-100
In Commercial Distribution

  • 05707480042081 ()
814940-100

  • Polysomnograph
Thermistor, Battery Box
Ambu A/S
814980-100
In Commercial Distribution

  • 05707480042067 ()
814980-100

  • Polysomnograph
Ref. 1464
Ambu A/S
814310-121
Not in Commercial Distribution

  • 05707480042043 ()
814310-121

  • Polysomnograph
Thermistor w. safety pins
Ambu A/S
814900-100
In Commercial Distribution

  • 05707480042036 ()
814900-100

  • Polysomnograph
Ref. 1439C (Cable, Interface & 10 sencors)
Ambu A/S
814901-000
In Commercial Distribution

  • 05707480042029 ()

  • Infant
814901-000

  • Polysomnograph
Ref. 1439B (Cable, Interface & 10 sencors)
Ambu A/S
814902-000
Not in Commercial Distribution

  • 05707480042012 ()
  • 05707480101344 ()

  • Pediatric
814902-000

  • Polysomnograph
One Channel Thermistor, Adult
Ambu A/S
814903-000
In Commercial Distribution

  • 05707480042005 ()

  • Adult
814903-000

  • Polysomnograph
Ref. 1418 CannuTherm-Reusable Thermal Sencor
Ambu A/S
814840-100
In Commercial Distribution

  • 05707480041985 ()
  • 05707480096619 ()
814840-100

  • Polysomnograph
Thermocouple Airflow Inf/Ped
Ambu A/S
814805-100
In Commercial Distribution

  • 05707480041954 ()
814805-100

  • Polysomnograph
Thermocouple w/safety pins (Sleepmate item 1401)
Ambu A/S
814810-100
In Commercial Distribution

  • 05707480041923 ()
  • 05707480096572 ()
814810-100

  • Polysomnograph
UARS Disposable Sensors, Sleepmate Min. purchase 10 pcs. = 1 pack Sleepmate no. 1601
Ambu A/S
816400-000/10
In Commercial Distribution

  • 05707480041909 ()
  • 05707480134014 ()
816400-000/10

  • Polysomnograph
UARS Starter Kit
Ambu A/S
816400-100
In Commercial Distribution

  • 05707480041893 ()
816400-100

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

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

  • Polysomnograph
Ref. 14869
Ambu A/S
814310-000/50
In Commercial Distribution

  • 05707480041879 ()
  • 05707480133970 ()
814310-000/50

  • Polysomnograph
Ref. 14868
Ambu A/S
814300-000/50
In Commercial Distribution

  • 05707480041862 ()
  • 05707480133932 ()

  • Adult
814300-000/50

  • Polysomnograph
Ref. 14867, Industry Standard CO2
Ambu A/S
814320-000/25
Not in Commercial Distribution

  • 05707480041855 ()
  • 05707480133994 ()
814320-000/25

  • Polysomnograph
Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

  • 05707480041848 ()
  • 05707480133918 ()
814320-000/50

  • Polysomnograph
Luer to O2 Adapter
Ambu A/S
814340-000
In Commercial Distribution

  • 05707480041800 ()
814340-000

  • Polysomnograph
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