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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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Sense System with IBT Electrodes - 00850004850114

Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips with Wrist)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-9
In Commercial Distribution

  • 00850004850114 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850077

Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow (Hand with grips with Wrist)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-5
In Commercial Distribution

  • 00850004850077 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

DreamStation - 00606959025509

DreamStation BiPAP Pro with Humidifier, with Heated Tube, with Cellular Modem, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, w/Cell, AHP
Not in Commercial Distribution

  • 00606959025509 ()
AHX600T11C

  • Home BPAP unit

TRACOE comfort - 04035324022328

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-09A-N
In Commercial Distribution

  • 04035324022328 ()

  • Lumen/Inner Diameter: 7.6 Millimeter
REF 888-104-09A-N

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324022236

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-08A-N
In Commercial Distribution

  • 04035324022236 ()

  • Lumen/Inner Diameter: 6.8 Millimeter
REF 888-104-08A-N

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324022151

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-07A-N
In Commercial Distribution

  • 04035324022151 ()

  • Lumen/Inner Diameter: 5.8 Millimeter
REF 888-104-07A-N

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324022069

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-06A-N
In Commercial Distribution

  • 04035324022069 ()

  • Lumen/Inner Diameter: 4.8 Millimeter
REF 888-104-06A-N

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324021970

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-05A-N
In Commercial Distribution

  • 04035324021970 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
REF 888-104-05A-N

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE® comfort - 04035324021888

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-04A-N
Not in Commercial Distribution

  • 04035324021888 ()

  • Lumen/Inner Diameter: 3.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324021802

Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-03A-N
Not in Commercial Distribution

  • 04035324021802 ()

  • Lumen/Inner Diameter: 2.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
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