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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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Welch Allyn, Inc. - 00732094250886

CONNEX CSAS CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250886 ()
106901

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094247282

68NCDP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
Not in Commercial Distribution

  • 00732094247060 ()
  • 00732094247282 ()
68NCDP

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094244298

106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094244298 ()
106900

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294699

CONNEX CENTRAL STATION 1.8 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294699 ()
107205

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294682

CONNEX CENTRAL STATION 1.8 - HW & SW
WELCH ALLYN, INC.
901066
Not in Commercial Distribution

  • 00732094294682 ()
107204

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294675

CSAS 1.8 CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294675 ()
107203

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294668

CONNEX CSAS 1.8 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294668 ()
107202

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094105254

Welch Allyn Series 300 Vital Signs Monitor with Nellcor SpO2, SureTemp Plus Thermometry, Non-invasive Blood Pressure, Pulse Rate, MAP; Supports Adult, Pediatric, and Neonatal Patients; 230 V, 50 Hz AC, IEC Plug Type-E/F
WELCH ALLYN, INC.
901057
Not in Commercial Distribution

  • 00732094105254 ()
53NT0-E4

  • Multiple vital physiological parameter monitoring system, clinical

Inspire - 00855728005949

The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-003
In Commercial Distribution

  • 00855728005949 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing

TrackX - 00857088008769

The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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