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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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BD Intelliport System - 00382905168031

SYRINGE LABELER INK CARTRIDGE
BECTON, DICKINSON AND COMPANY
516803
In Commercial Distribution

  • 60382905168033 ()
  • 00382905168031 ()
  • 50382905168036 ()
516803

  • Intravenous injection automated detection/documentation system processor/transmitter

BD Intelliport System - 00382905168024

SYRINGE LABELER BARREL LABEL ROLL
BECTON, DICKINSON AND COMPANY
516802
In Commercial Distribution

  • 60382905168026 ()
  • 00382905168024 ()
  • 50382905168029 ()
516802

  • Intravenous injection automated detection/documentation system processor/transmitter

BD Intelliport System - 00382905168017

SYRINGE LABELER LUER LABEL CASSETTE
BECTON, DICKINSON AND COMPANY
516801
In Commercial Distribution

  • 50382905168012 ()
  • 00382905168017 ()
  • 60382905168019 ()
516801

  • Intravenous injection automated detection/documentation system processor/transmitter

Natus - 00382830058506

Neonatal Sensors
XLTEK
CZA00037
In Commercial Distribution

  • 00382830007443 ()
  • 00382830058506 ()


  • Analytical scalp electrode, single-use

Tandem Source - 00389152106113

Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display

Dexcom API - 00386270000668

Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

AI-Rad Companion Organs RT - 04068151010404

No Description
Siemens Healthcare GmbH
11823875
In Commercial Distribution

  • 04068151010404 ()


  • Radiology DICOM image processing application software

NA - 00841983102592

BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution

  • 00841983102592 ()
QI-123A

  • Electroencephalograph

NA - 00841983101199

EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-124A
In Commercial Distribution

  • 00841983101199 ()
QI-124A

  • Electroencephalograph

NA - 00841983100659

Electrode junction box (256 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983100659 ()
JE-120A-24

  • Electroencephalograph
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