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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Alinity i Intact PTH Controls
Abbott GmbH
08P3110
Not in Commercial Distribution

  • 00380740136208 ()
08P3110

  • Parathyroid hormone (PTH) IVD, control
Alinity i CA 19-9XR Controls
Abbott GmbH
08P3210
In Commercial Distribution

  • 00380740135492 ()
08P3210

  • Cancer antigen 19-9 (CA19-9) IVD, control
Alinity i CA 15-3 Controls
Abbott GmbH
08P5110
In Commercial Distribution

  • 00380740135430 ()
08P5110

  • Cancer antigen 15-3 (CA15-3) IVD, control
Alinity i B_hCG Assay File
Abbott GmbH
07P515A
In Commercial Distribution

  • 00380740160807 ()
07P515A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-20
Not in Commercial Distribution

  • 00380740159412 ()
04P5520

  • Laboratory instrument/analyser application software IVD
Alinity i Active-B12 (Holotranscobalamin) Controls
Abbott GmbH
09P2610
In Commercial Distribution

  • 00380740150518 ()
09P2610

  • Vitamin B12 IVD, control
Alinity i Active-B12 (Holotranscobalamin) Calibrators
Abbott GmbH
09P2601
In Commercial Distribution

  • 00380740150501 ()
09P2601

  • Vitamin B12 IVD, calibrator
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-17
Not in Commercial Distribution

  • 00380740150143 ()
04P5517

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBs Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD
Alinity i iPTH Assay File
Abbott GmbH
08P311A
In Commercial Distribution

  • 00380740146658 ()
08P311A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBc IgM Controls
Abbott GmbH
07P8612
In Commercial Distribution

  • 00380740145187 ()
07P8612

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Alinity i Estradiol Assay File
Abbott GmbH
07P501A
In Commercial Distribution

  • 00380740143091 ()
07P501A

  • Laboratory instrument/analyser application software IVD
Alinity i Prolactin Assay File
Abbott GmbH
07P661A
In Commercial Distribution

  • 00380740143084 ()
07P661A

  • Laboratory instrument/analyser application software IVD
Alinity i Syphilis Assay File
Abbott GmbH
07P601A
In Commercial Distribution

  • 00380740143008 ()
07P601A

  • Laboratory instrument/analyser application software IVD
Alinity i Folate Assay File
Abbott GmbH
08P141A
In Commercial Distribution

  • 00380740142933 ()
08P141A

  • Laboratory instrument/analyser application software IVD
Alinity i CEA Assay File
Abbott GmbH
07P621A
In Commercial Distribution

  • 00380740142889 ()
07P621A

  • Laboratory instrument/analyser application software IVD
Alinity i Ferritin Assay File
Abbott GmbH
07P651A
In Commercial Distribution

  • 00380740142834 ()
07P651A

  • Laboratory instrument/analyser application software IVD
Alinity i T-Uptake Assay File
Abbott GmbH
08P121A
In Commercial Distribution

  • 00380740142810 ()
08P121A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HCV Assay File
Abbott GmbH
08P051B
In Commercial Distribution

  • 00380740142155 ()
08P051B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-16
Not in Commercial Distribution

  • 00380740139520 ()
04P5516

  • Laboratory instrument/analyser application software IVD
Alinity i TSH Assay File
Abbott GmbH
07P481A
In Commercial Distribution

  • 00380740138899 ()
07P481A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD
Alinity i Progesterone Manual Diluent
ABBOTT IRELAND
08P3640
In Commercial Distribution

  • 00380740136710 ()
08P3640

  • Progesterone IVD, kit, chemiluminescent immunoassay
Alinity i Multi-Assay Manual Diluent
Abbott Ireland Diagnostics
09P1540
In Commercial Distribution

  • 00380740131678 ()
09P1540

  • Buffered sample diluent IVD
Alinity i Intact PTH Calibrators
Abbott GmbH
08P3101
Not in Commercial Distribution

  • 00380740131586 ()
08P3101

  • Parathyroid hormone (PTH) IVD, calibrator
Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i Total T4 Controls
ABBOTT IRELAND
07P9510
In Commercial Distribution

  • 00380740131500 ()
07P9510

  • Total thyroxine (TT4) IVD, control
Alinity i Total T4 Calibrators
ABBOTT IRELAND
07P9501
In Commercial Distribution

  • 00380740131494 ()
07P9501

  • Total thyroxine (TT4) IVD, calibrator
Alinity i CA 15-3 Calibrators
Abbott GmbH
08P5101
In Commercial Distribution

  • 00380740131425 ()
08P5101

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator
Alinity i HAVAb IgG Calibrator
Abbott GmbH
08P2701
In Commercial Distribution

  • 00380740131357 ()
08P2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Free T3 Controls
ABBOTT IRELAND
07P6910
In Commercial Distribution

  • 00380740131098 ()
07P6910

  • Free triiodothyronine (FT3) IVD, control
Alinity i Free T3 Calibrators
ABBOTT IRELAND
07P6901
In Commercial Distribution

  • 00380740131081 ()
07P6901

  • Free triiodothyronine (FT3) IVD, calibrator
CATH I W SPLIT DRAPE
Cardinal Health 200, LLC
SAN73CASF5
In Commercial Distribution

  • 50888439382288 ()
  • 10888439382280 ()
SAN73CASF5

  • Cardiothoracic surgical procedure kit, medicated, single-use
PACK,CYSTOSCOPY,PK I,AURORA
MEDLINE INDUSTRIES, INC.
DYNJP5000A
In Commercial Distribution

  • 40080196778370 ()
  • 10080196778379 ()
DYNJP5000A

  • General surgical procedure kit, non-medicated, single-use
DBD-PACK,LAPAROTOMY,PK I,PEDIATRIC
MEDLINE INDUSTRIES, INC.
DYNJP3080
In Commercial Distribution

  • 10080196739516 ()
DYNJP3080

  • General surgical procedure kit, non-medicated, single-use
PACK,EENT,STERILE,PK I
MEDLINE INDUSTRIES, INC.
DYNJP7000
In Commercial Distribution

  • 40080196733812 ()
  • 10080196733811 ()
DYNJP7000

  • General surgical procedure kit, non-medicated, single-use
CATH I W SPLIT DRAPE
Cardinal Health 200, LLC
SAN73CASF4
In Commercial Distribution

  • 50888439335857 ()
  • 10888439335859 ()
SAN73CASF4

  • Cardiothoracic surgical procedure kit, medicated, single-use
DBD-PACK,LAPAROSCOPY,PK I,SIRUS
MEDLINE INDUSTRIES, INC.
DYNJP9100S
In Commercial Distribution

  • 40080196309178 ()
  • 10080196309177 ()
DYNJP9100S

  • General surgical procedure kit, non-medicated, single-use
DBD-PACK,EENT,SIRUS,PK I
MEDLINE INDUSTRIES, INC.
DYNJP7000S
In Commercial Distribution

  • 40080196308911 ()
  • 10080196308910 ()
DYNJP7000S

  • Surgical/examination garment kit
DBD-PACK,LAPAROTOMY,PK I,SIRUS
MEDLINE INDUSTRIES, INC.
DYNJP3000S
In Commercial Distribution

  • 40080196308218 ()
  • 10080196308217 ()
DYNJP3000S

  • General surgical procedure kit, non-medicated, single-use
CUSTOM PACK CB2978R1 SUPPORT I
MEDTRONIC, INC.
CB2978R1
Not in Commercial Distribution

  • 00613994132314 ()


  • Cardiopulmonary bypass system blood tubing set
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPNW4
In Commercial Distribution

  • 50887488950714 ()
  • 10887488950716 ()
SAN31LPNW4

  • Angiography kit
KIT, E A S I
Cardinal Health 200, LLC
SPKCG00410
In Commercial Distribution

  • 50887488969426 ()
  • 10887488969428 ()
SPKCG00410

  • General surgical procedure kit, medicated
DBS,PART I ELECTRODE INSERTION
Cardinal Health 200, LLC
SNE51DBUS5
In Commercial Distribution

  • 50887488958826 ()
  • 10887488958828 ()
SNE51DBUS5

  • Neurosurgical procedure kit, medicated
STERILE I AND D PACK
Cardinal Health 200, LLC
05-2797I
In Commercial Distribution

  • 50887488848042 ()
  • 10887488848044 ()
05-2797I

  • General surgical procedure kit, medicated
STERILE I AND D PACK
Cardinal Health 200, LLC
05-2797H
In Commercial Distribution

  • 50887488839767 ()
  • 10887488839769 ()
05-2797H

  • General surgical procedure kit, medicated
DBS,PART I ELECTRODE INSERTION
Cardinal Health 200, LLC
SNE51DBUSS
In Commercial Distribution

  • 50887488854005 ()
  • 10887488854007 ()
SNE51DBUSS

  • Neurosurgical procedure kit, medicated
DBS,PART I ELECTRODE INSERTION
Cardinal Health 200, LLC
SNE51DBUS4
In Commercial Distribution

  • 50887488932048 ()
  • 10887488932040 ()
SNE51DBUS4

  • Neurosurgical procedure kit, medicated
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