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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 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

Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges - 04987270260340

No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

Lumipulse G Testosterone Immunoreaction Cartridges - 04987270235393

No Description
FUJIREBIO INC.
235393
In Commercial Distribution

  • 04987270235393 ()

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


  • Total testosterone IVD, kit, chemiluminescent immunoassay

Lumipulse G TSH-III Immunoreaction Cartridges - 04987270235294

No Description
FUJIREBIO INC.
235294
Not in Commercial Distribution

  • 04987270235294 ()

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


  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Lumipulse G LH Immunoreaction Cartridges - 04987270235270

No Description
FUJIREBIO INC.
235270
Not in Commercial Distribution

  • 04987270235270 ()

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


  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Progesterone-N Immunoreaction Cartridges - 04987270235256

No Description
FUJIREBIO INC.
235256
Not in Commercial Distribution

  • 04987270235256 ()

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


  • Progesterone IVD, kit, chemiluminescent immunoassay

Lumipulse G BHCG Immunoreaction Cartridges - 04987270235232

No Description
FUJIREBIO INC.
235232
In Commercial Distribution

  • 04987270235232 ()

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


  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay

Lumipulse G FSH-N Immunoreaction Cartridges - 04987270235218

No Description
FUJIREBIO INC.
235218
Not in Commercial Distribution

  • 04987270235218 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Prolactin Immunoreaction Cartridges - 04987270235195

No Description
FUJIREBIO INC.
235195
Not in Commercial Distribution

  • 04987270235195 ()

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


  • Prolactin IVD, kit, chemiluminescent immunoassay

Lumipulse G E2-III Immunoreaction Cartridges - 04987270235171

No Description
FUJIREBIO INC.
235171
In Commercial Distribution

  • 04987270235171 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Lumipulse G Mesothelin Immunoreaction Cartridges - 04987270235157

No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

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


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 19-9-N Immunoreaction Cartridges - 04987270235126

No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

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


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 15-3 Immunoreaction Cartridges - 04987270235102

No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

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


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges - 04987270235089

No Description
FUJIREBIO INC.
235089
Not in Commercial Distribution

  • 04987270235089 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 04987270235058

No Description
FUJIREBIO INC.
235058
In Commercial Distribution

  • 04987270235058 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Lumipulse BRAHMS PCT Controls - 04987270234945

No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

  • Size Type =Units per Kit; Units = 14; Unit of Measure = 20mLs


  • Procalcitonin (PCT) IVD, control

Lumipulse G BRAHMS PCT Calibrator Set - 04987270234938

No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

  • Size Type = Units per Kit; Units = 5; Unit of Measure = 10mLs


  • Procalcitonin (PCT) IVD, calibrator

Lumipulse B-Amyloid Controls - 04987270234907

No Description
FUJIREBIO INC.
234907
In Commercial Distribution

  • 04987270234907 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G Specimen Diluent 6 - 04987270234693

No Description
FUJIREBIO INC.
234693
In Commercial Distribution

  • 04987270234693 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G CA125II Immunoreaction Cartridges - 04987270234273

No Description
FUJIREBIO INC.
234273
In Commercial Distribution

  • 04987270234273 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Lumipulse G HE4 Calibrators - 04987270234181

No Description
FUJIREBIO INC.
234181
Not in Commercial Distribution

  • 04987270234181 ()

  • Size Type = Units Per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human epididymis protein 4 (HE4) IVD, calibrator

Lumipulse G HE4 Immunoreaction Cartridges - 04987270234174

No Description
FUJIREBIO INC.
234174
Not in Commercial Distribution

  • 04987270234174 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Lumipulse G 25-OH Vitamin D Calibrators - 04987270234020

No Description
FUJIREBIO INC.
234020
Not in Commercial Distribution

  • 04987270234020 ()

  • Size Type = Units per Kit; Units = 6; Units of measure = 1.5mL


  • Multiple form 25-hydroxy Vitamin D IVD, calibrator

Lumipulse G E2-III Calibrators - 04987270233849

No Description
FUJIREBIO INC.
233849
In Commercial Distribution

  • 04987270233849 ()

  • Size Type = Units Per Kit; Units = 3; Unit of Measure = 4.5mLs


  • Estradiol (oestradiol) (E2) IVD, calibrator

Lumipulse G Mesothelin Calibrator - 04987270233436

No Description
FUJIREBIO INC.
233436
In Commercial Distribution

  • 04987270233436 ()

  • Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs


  • Soluble mesothelin-related peptide (SMRP) IVD, calibrator

Lumipulse SARS-CoV-2 Ag Controls - 04987270231876

No Description
FUJIREBIO INC.
231876
In Commercial Distribution

  • 04987270231876 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, control

Lumipulse G SARS-CoV-2 Ag Calibrator Set - 04987270231869

No Description
FUJIREBIO INC.
231869
In Commercial Distribution

  • 04987270231869 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, calibrator

Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges - 04987270231753

No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges - 04987270231432

No Description
FUJIREBIO INC.
231432
In Commercial Distribution

  • 04987270231432 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Altor Safety - G023622321

Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622321Z2 ()
  • G023622321 ()
62232

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

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

Altor Safety - G023622222

Altor Safety 3-Ply Surgical Mask (Model:62222) Outer Case of 2,000 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622222Z2 ()
  • G023622222 ()


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

Altor Safety - G023622221

Altor Safety 3-Ply Surgical Mask (Model:62222) Inner Carton of 50 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622221 ()


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

BD GasPak™ Catalyst Replacement Charges - 30382902703038

BD GasPak™ Catalyst Replacement Charges
BECTON, DICKINSON AND COMPANY
270303
Not in Commercial Distribution

  • 30382902703038 ()
  • 00382902703037 ()
270303

  • Atmospheric generation kit IVD

ELMED INCORPORATED - 00198506083181

Epstein Abdominoplasty Retractor, 240x27mm blade with 60mm wide working end with teeth, with ergonomic handle,with Fiberoptic, with Suction
ELMED INCORPORATED
37322-26FS
In Commercial Distribution

  • 00198506083181 ()
37322-26FS

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle

Fixation Forceps with teeth - 00883475953718

No Description
CHARMANT INC.
37-0075
In Commercial Distribution

  • 00883475953718 ()


  • Ophthalmic surgical device handling forceps, reusable

Caliper with Handle(G) - 00883475952988

No Description
CHARMANT INC.
37-0064
In Commercial Distribution

  • 00883475952988 ()


  • Corneal marker, reusable

Speculum with Locking Screw - 00883475952957

No Description
CHARMANT INC.
37-0063
In Commercial Distribution

  • 00883475952957 ()


  • Eyelid speculum, reusable

Fixation Forceps with teeth - 00883475952285

No Description
CHARMANT INC.
37-0060
In Commercial Distribution

  • 00883475952285 ()


  • Ophthalmic surgical device handling forceps, reusable

Wire Speculum with Blade - 00883475651386

No Description
CHARMANT INC.
37-0010
In Commercial Distribution

  • 00883475651386 ()


  • Eyelid speculum, reusable

Tip with Indexable Stop - 08057639710574

Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic

iReveal with PowerLook AMP - 00858012005656

PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software

Tri-Seal mouthseal with mouthpiece - 00850644007589

blue vinyl, 22mm OD, 50/bx
Vacumed
1007-MP
In Commercial Distribution

  • 00850644007589 ()
  • 08506440075896 ()
1007-MP

  • Breathing mouthpiece, single-use

Inspirachamber with InspiraMask (Large) - 00852367007013

InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit
INSPIRX, INC
IC-IML-0
In Commercial Distribution

  • 00852367007013 ()
  • 10852367007010 ()


  • Medicine chamber spacer, reusable

FlexGuide ULTRA with Tray - 00852306007302

FlexGuide ULTRA set with Fleguide Handpiece and Tray
OMNIGUIDE, INC.
FLEX-ULTRA SET
In Commercial Distribution

  • 00852306007302 ()
FLEX-ULTRA SET

  • Urogenital surgical laser system beam guide, reusable

AP70(with long antenna) - 06936415973537

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-071010-00
In Commercial Distribution

  • 06936415973537 ()


  • General-purpose multi-parameter bedside monitor

TOGGLELOC XL WITH ZIPLOOP - 00880304567641

No Description
Biomet Orthopedics, LLC
110005089
In Commercial Distribution

  • 00880304567641 ()
110005089

  • Ligament bone anchor
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