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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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Mini Master Series - 00190746108396

DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2002
In Commercial Distribution

  • 00190746108396 ()
310-2002

  • Orthodontic bracket, metal

Mini Master Series - 00190746108389

DB BKT MINI MS UL CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1022
In Commercial Distribution

  • 00190746108389 ()
310-1022

  • Orthodontic bracket, metal

Mini Master Series - 00190746108372

DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1002
In Commercial Distribution

  • 00190746108372 ()
310-1002

  • Orthodontic bracket, metal

Mini Master Series - 00190746108365

DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2021
In Commercial Distribution

  • 00190746108365 ()
310-2021

  • Orthodontic bracket, metal

Mini Master Series - 00190746108358

DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2001
In Commercial Distribution

  • 00190746108358 ()
310-2001

  • Orthodontic bracket, metal

Mini Master Series - 00190746108341

DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1021
In Commercial Distribution

  • 00190746108341 ()
310-1021

  • Orthodontic bracket, metal

Mini Master Series - 00190746108334

DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1001
In Commercial Distribution

  • 00190746108334 ()
310-1001

  • Orthodontic bracket, metal

Trackit - 05060275450257

No Description
LIFELINES LIMITED
Trackit 24/0 Kit
In Commercial Distribution

  • 05060275450257 ()
2123B

  • Electroencephalographic ambulatory recorder

STAT PROFILE - 00385480489041

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480451505

Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480356381

STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480341172

STAT PROFILE pHOx PLUS L CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus L
In Commercial Distribution

  • 00385480341172 ()
  • 00385489341173 ()
34117

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340939

Stat Profile pHOx Plus L Controls Auto-Cartridge, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340939 ()
34093

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340922

Stat Profile pHOx Plus L Controls Auto-Cartridge, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340922 ()
34092

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340915

Stat Profile pHOx Plus L Controls Auto-Cartridge, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340915 ()
34091

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340908

Stat Profile pHOx Plus L Controls Auto-Cartridge, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340908 ()
34090

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306461

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306454

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306447

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306430

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480278966

STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239332

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239325

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239318

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239301

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480227636

STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489034

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Positive Serum Control - 10888234500612

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500605

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution

  • 10888234500605 ()
404596

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Aurora Xi Software - 04086000101516

Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system

Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed - 04086000100991

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2367
In Commercial Distribution

  • 14086000100998 ()
  • 04086000100991 ()
4R2367

  • Apheresis system tubing set

Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed - 04086000100984

For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2365
In Commercial Distribution

  • 04086000100984 ()
  • 14086000100981 ()
4R2365

  • Apheresis system tubing set

Aurora Plasmapheresis System - 04086000100236

Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Fresenius Kabi AG
6R4601
In Commercial Distribution

  • 04086000100236 ()
6R4601

  • Apheresis system

ALYX 2RBC LR KIT - 04086000100199

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5720
In Commercial Distribution

  • 04086000100199 ()
  • 14086000100196 ()
X4R5720

  • Apheresis system tubing set

Acrodose PLus System - 10887691310697

Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
HAEMONETICS CORPORATION
732-83
In Commercial Distribution

  • 30887691310691 ()
  • 10887691310697 ()


  • Blood/tissue storage/culture container

Negative Serum Control - 10888234500513

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution

  • 10888234500513 ()
404573

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500506

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution

  • 10888234500506 ()
404572

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500469

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500452

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
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