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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 - 00817377020162

Perfect Fit II Pediatric Alice 5 Effort Belt Sensor, Chest
DYMEDIX DIAGNOSTICS, INC.
11-22303-0301
In Commercial Distribution

  • 00817377020162 ()


  • Polysomnograph

Perfect Fit - 00817377020155

Perfect Fit™II Pediatric Effort Belt Sensor, Chest
DYMEDIX DIAGNOSTICS, INC.
11-22300-0301
In Commercial Distribution

  • 00817377020155 ()


  • Polysomnograph

Perfect Fit - 00817377020148

Perfect Fit™Pediatric Effort Belt Sensor, Abdomen
DYMEDIX DIAGNOSTICS, INC.
11-22200-0301
In Commercial Distribution

  • 00817377020148 ()


  • Polysomnograph

Perfect Fit - 00817377020131

Perfect Fit™ 3D Effort Belt Strap, 50 yard roll
DYMEDIX DIAGNOSTICS, INC.
11-14001-5001
In Commercial Distribution

  • 10817377020138 ()
  • 00817377020131 ()


  • Polysomnograph

Perfect Fit - 00817377020124

Perfect Fit™Pediatric Effort Belt Sensor, Chest
DYMEDIX DIAGNOSTICS, INC.
11-22100-0301
In Commercial Distribution

  • 00817377020124 ()


  • Polysomnograph

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 Cable for Disposable RIP - B14085780

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 head box or a DC amplifier.
Braebon Medical Corporation
8578
In Commercial Distribution

  • B14085780 ()

  • Length: 14 Inch
8578

  • Electrical-only medical device connection cable, reusable

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 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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