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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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Crest Healthcare Supply
02100166W
In Commercial Distribution

  • B48402100166W0 ()


  • Nurse call system
XN series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Ektacom nurse call system.
Crest Healthcare Supply
XN15CCEIXXXXTAAYL
Not in Commercial Distribution

  • XN15CCEIXXXXTAAYL0 ()

  • Length: 8 Feet


  • Nurse call system
XN series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Ektacom nurse call system.
Crest Healthcare Supply
XN08CCEIXXXXTAAYL
Not in Commercial Distribution

  • XN08CCEIXXXXTAAYL0 ()

  • Length: 8 Feet


  • Nurse call system
XL series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Executone nurse call system.
Crest Healthcare Supply
XL01YRRSXXXZZZ1
Not in Commercial Distribution

  • XL01YRRSXXXZZZ10 ()

  • Length: 8 Feet


  • Nurse call system
Nurse Call Switch Communication System non-powered
Med Labs Inc
E-Z Call
In Commercial Distribution

  • G395EZCALL1 ()


  • Nurse call system
No Description
OcuSciences, Inc.
OCUB100
In Commercial Distribution

  • G744OCUB100 ()


  • Scanning-laser retinal imaging system
No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system
Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution

  • BN981BN002023 ()
BN002-02

  • Surgical planning/navigation-enhancement system
Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution

  • BN981BN001021 ()
BN001-02

  • Surgical planning/navigation-enhancement system
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device.
Heidelberg Medical Inc
Heidelberg pH Telemetric Capsules
In Commercial Distribution

  • B989HTC1020 ()
HTC102

  • Gastrointestinal telemetric monitoring system capsule, ingestible
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