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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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Saltillo - 00816486021015

TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer

Invisalign Palatal Expander - 00816063021391

Palatal Expanders
Align Technology, Inc.
9031
In Commercial Distribution

  • 00816063021391 ()


  • Orthodontic palate expander/teeth aligner, self-removable

Invisalign Palatal Holder - 00816063021384

Palatal Holder
Align Technology, Inc.
9032
In Commercial Distribution

  • 00816063021384 ()


  • Orthodontic retainer

Ivenix Infusion System - 00811505030450

Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-07
In Commercial Distribution

  • 00811505030450 ()
IMS

  • Infusion pump medication-dosage application software

Ivenix Infusion System - 00811505030443

Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-06
In Commercial Distribution

  • 00811505030443 ()
IMS

  • Infusion pump medication-dosage application software

Ivenix Infusion System - 00811505030399

Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
In Commercial Distribution

  • 00811505030399 ()
IMS

  • Infusion pump medication-dosage application software

Ivenix Infusion System - 00811505030351

Infusion Management System (IMS), version 4.0.0
Fresenius Kabi AG
4.0.0
In Commercial Distribution

  • 00811505030351 ()
IMS-0700

  • Infusion pump medication-dosage application software

Ivenix Infusion System - 00811505030177

Infusion Management System (IMS) Version 3.0.0
Fresenius Kabi AG
3.0.0
In Commercial Distribution

  • 00811505030177 ()
IMS-0600

  • Infusion pump medication-dosage application software

Ivenix, Inc. - 00811505030016

Infusion Management System (IMS), version 2.0
Fresenius Kabi AG
2.0
Not in Commercial Distribution

  • 00811505030016 ()
IMS-0500

  • Infusion pump medication-dosage application software

Ivenix Infusion System - 00811050530399

Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
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