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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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Lumipulse G CA 15-3 Calibrators - 04987270230640

No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

Lumipulse G whole PTH Immunoreaction Cartridges - 04987270230190

No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Emit II Plus Oxycodone Assay 30 mL Kit - 00630414028019

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720808
In Commercial Distribution

  • 00630414028019 ()
9T039UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 115 mL Kit - 00630414027937

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 1 L Kit - 00630414027920

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Medline - 10080196073320

BAG,BANDED,CIRCULAR,STERILE,20"
MEDLINE INDUSTRIES, INC.
DYNJE60020S
In Commercial Distribution

  • 10080196073320 ()
DYNJE60020S

  • Sterilization packaging, single-use

Altor Safety - 00850019086201

Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use

BD BBL™ GasPak™ 100 Anaerobic System, Vented - 00382902606277

BD BBL™ GasPak™ 100 Anaerobic System, Vented
BECTON, DICKINSON AND COMPANY
260627
Not in Commercial Distribution

  • 00382902606277 ()
260627

  • Atmospheric generation kit IVD

BD BBL™ GasPak™ 100 Anaerobic System - 00382902606260

BD BBL™ GasPak™ 100 Anaerobic System
BECTON, DICKINSON AND COMPANY
260626
Not in Commercial Distribution

  • 00382902606260 ()
260626

  • Atmospheric generation kit IVD

Altor Safety - G023622320

Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622320 ()
62232

  • Surgical/medical face mask, non-antimicrobial, single-use
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