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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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Perfect Fit - 00817377022081

Interface Cable, FastTrack, Abdomen, Alice 6
DYMEDIX DIAGNOSTICS, INC.
12-42016-0001
In Commercial Distribution

  • 00817377022081 ()


  • Polysomnograph

Perfect Fit - 00817377022074

Interface Cable, FastTrack, Chest, Grael
DYMEDIX DIAGNOSTICS, INC.
12-42015-0001
In Commercial Distribution

  • 00817377022074 ()


  • Polysomnograph

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

BRAEBON Oral Thermocouple Airflow Sensor - B140B12210

Oral only thermocouple intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.
Braebon Medical Corporation
B1220
In Commercial Distribution

  • B140B12210 ()
B1220

  • General-purpose patient temperature probe, reusable

Q-RIP to Belt Controller Cable for Alice - B1408592A0

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592A
In Commercial Distribution

  • B1408592A0 ()

  • Length: 48 Inch
8592A

  • Pneumograph

BRAEBON RIP Belt for MediByte - B14085920

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592
In Commercial Distribution

  • B14085920 ()

  • Length: 48 Inch
8592

  • Pneumograph

BRAEBON RIP Belt for MediByte, Pediatric - B1408572PED0

Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Braebon Medical Corporation
8572PED
In Commercial Distribution

  • B1408572PED0 ()

  • Length: 24 Inch
8572PED

  • Pneumograph

BRAEBON cTherm Cannula Thermistor for MediByte with Lemo - B1408514L0

Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.
Braebon Medical Corporation
8514L
In Commercial Distribution

  • B1408514L0 ()
8514L

  • General-purpose patient temperature probe, reusable

BRAEBON cTherm Cannula Thermistor for MediByte - B14085140

Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.
Braebon Medical Corporation
8514
In Commercial Distribution

  • B14085140 ()
8514

  • General-purpose patient temperature probe, reusable

BRAEBON Cable for MediByte Disposable Airflow Sensor - B1408510BS0

Cable for attaching the MediByte Disposable Airflow Sensor.
Braebon Medical Corporation
8510BS
In Commercial Distribution

  • B1408510BS0 ()
8510BS

  • Electrical-only medical device connection cable, reusable
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