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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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Dr.PRP - 08809410200060

The Dr. PRP is an individually packaged sterile, single-use, disposable concentrating unit composed of medical-grade polymer and elastomer. The concentrating unit has 20ml of volume capacity and is designed to work with a sing rotor type general-purpose centrifuge.
Rmedica Co.,Ltd
Dr.PRP
In Commercial Distribution

  • 08809410200060 ()
RMLFT-001(EN)

  • Apheresis system

Dr.PRP - 08809410200008

The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general-purpose centrifuge.
Rmedica Co.,Ltd
Dr.PRP
In Commercial Distribution

  • 08809410200008 ()
RMLFT-001(EN)

  • Apheresis system

Haemonetics - 10887691313940

High Efficiency Post-Process Filter System for Leukocyte Removal From Red Cells
HAEMONETICS CORPORATION
BPFAPLUS
In Commercial Distribution

  • 10887691313940 ()
  • 30887691313944 ()


  • Blood transfusion filter

Acrodose PLus System - 10887691310680

Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS
HAEMONETICS CORPORATION
732-82
In Commercial Distribution

  • 30887691310684 ()
  • 10887691310680 ()


  • Blood/tissue storage/culture container

Acrodose PL System - 10887691307888

Platelet Pool and Store Set with eBDS
HAEMONETICS CORPORATION
732-80
In Commercial Distribution

  • 30887691307882 ()
  • 10887691307888 ()


  • Blood/tissue storage/culture container

Haemonetics - 10887691305792

LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 mL Transfer Bag
HAEMONETICS CORPORATION
LRF6BLA
In Commercial Distribution

  • 30887691305796 ()
  • 10887691305792 ()


  • Blood transfusion filter

Haemonetics - 10887691305303

LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10BLA
In Commercial Distribution

  • 30887691305307 ()
  • 10887691305303 ()


  • Blood transfusion filter

Haemonetics Leukotrap SC RC - 10887691304214

Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter
HAEMONETICS CORPORATION
BPFBLA
In Commercial Distribution

  • 30887691304218 ()
  • 10887691304214 ()


  • Blood transfusion filter

Haemonetics - 10887691003872

Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port
HAEMONETICS CORPORATION
NEO1
In Commercial Distribution

  • 30887691003876 ()
  • 10887691003872 ()


  • Blood transfusion filter

Haemonetics - 10887691000758

BPF Leukocyte Reduction Filteration System
HAEMONETICS CORPORATION
BPFB
In Commercial Distribution

  • 30887691000752 ()
  • 10887691000758 ()


  • Blood transfusion filter

Haemonetics - 10887691000703

LRF High Efficiency Leukocyte Reduction Filtration System for Platelets
HAEMONETICS CORPORATION
LRFP
In Commercial Distribution

  • 30887691000707 ()
  • 10887691000703 ()


  • Blood transfusion filter

Haemonetics - 10887691000437

LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1.3L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10S
In Commercial Distribution

  • 30887691000431 ()
  • 10887691000437 ()


  • Blood transfusion filter

Selphyl PRP Tube - 00851802007113

Blood separation tube for PRP
Factor Medical, Inc.
0363
In Commercial Distribution

  • 00851802007113 ()

  • Total Volume: 9 Milliliter
0363

  • Haematological concentrate system preparation kit, platelet concentration

ABORhCard - 00815312020000

Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
MICRONICS, INC.
BT-101-025
In Commercial Distribution

  • 00815312020000 ()
  • 00815312020048 ()
BT-101-025

  • ABO/Rh multiple blood grouping IVD, kit, agglutination

CDCS (Cross Donation Check System) - 00812747010064

CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010064 ()


  • Clinical laboratory information system application software

NextGen - 00812747010057

NextGen version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010057 ()


  • Blood bank information system application software

SafeTrace Tx - 00812747010033

SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010033 ()


  • Blood bank information system application software

BloodSafe - 00812747010019

BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010019 ()


  • Clinical laboratory information system application software

NDDR (National Donor Deferral Registry) - 00812747010217

NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software

Donor Doc - 00812747010200

Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010200 ()


  • Configurable electronic form web-based application software

Symphony - 00812747010194

Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010194 ()


  • Blood bank information system application software

Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software

ElDorado Donor - 00812747010149

ElDorado Donor version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010149 ()


  • Blood bank information system application software

ElDorado Donor - 00812747010132

ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010132 ()


  • Blood bank information system application software

McKesson Blood Bank - 00812747010118

McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010118 ()


  • Blood bank information system application software

InstaMatch - 00812747010088

InstaMatch version 1.X.X
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010088 ()


  • Blood bank information system application software

Determine™ HIV–1/2 Ag/Ab Combo Controls - 00811877011125

The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
In Commercial Distribution

  • 00811877011125 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Determine™ HIV–1/2 Ag/Ab Combo - 00811877011101

Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
In Commercial Distribution

  • 00811877011101 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Aurora Xi - 00810020442199

Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system

Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual - 00810020441642

For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2361
In Commercial Distribution

  • 10810020441649 ()
  • 00810020441642 ()
4R2361

  • Apheresis system tubing set

Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual - 00810020441635

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2360
In Commercial Distribution

  • 10810020441632 ()
  • 00810020441635 ()
4R2360

  • Apheresis system tubing set

AMICUS Separator Legacy Software - 00810020441208

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020441192

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system

PLASMACELL Xi Disposable Set with SPIKESMART - 00810020441116

For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Fresenius Kabi AG
6R2600P
In Commercial Distribution

  • 10810020441113 ()
  • 00810020441116 ()
6R2600P

  • Apheresis system tubing set

Aurora Xi Plasmapheresis System - 00810020440898

Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike - 00810020440768

For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2359
In Commercial Distribution

  • 10810020440765 ()
  • 00810020440768 ()
4R2359

  • Apheresis system tubing set

Plasmalink Transfer-Pack Container - 2000 mL - 00810020440669

For processing and/or storage of blood and blood components. Sterile Fluid Path.
Fresenius Kabi AG
6R2042
In Commercial Distribution

  • 10810020440666 ()
  • 00810020440669 ()
6R2042

  • Blood/tissue storage/culture container

AMICUS Separator Life Extension Software - 00810020440607

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system

AMICUS Separator Legacy Software - 00810020440591

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system

Aurora Xi - 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system

Aurora Software Version 2.1C Upgrade - 00810020440300

AURORA Software Version 2.1C for collection of plasma by membrane filtration.
Fresenius Kabi AG
Version 2.1C
In Commercial Distribution

  • 00810020440300 ()
  • 10810020440307 ()
X6S4021USB

  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike - 00810020440270

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2358
In Commercial Distribution

  • 10810020440277 ()
  • 00810020440270 ()
4R2358

  • Apheresis system tubing set

AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440164

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353G
In Commercial Distribution

  • 10810020440161 ()
  • 00810020440164 ()
4R2353G

  • Apheresis system tubing set

AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

Tropocells - 07290015874380

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1650
In Commercial Distribution

  • 07290015874380 ()
ESTSN1650

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874359

No Description
ESTAR TECHNOLOGIES LTD
521254US
In Commercial Distribution

  • 07290015874359 ()
521254US

  • Haematological concentrate system preparation kit, platelet concentration

Eclipse PRP, Tropocells - 07290015874328

No Description
ESTAR TECHNOLOGIES LTD
26754E
In Commercial Distribution

  • 07290015874328 ()
26754E

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874311

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1690
In Commercial Distribution

  • 07290015874311 ()
ESTSN1690

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874229

No Description
ESTAR TECHNOLOGIES LTD
1253VTSF10
Not in Commercial Distribution

  • 07290015874229 ()
1253VTSF10

  • Haematological concentrate system preparation kit, platelet concentration
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