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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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SELPHYL® - 10851802007097

The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 9 mL SELPHYL® System is available as a single pack (item number 420910) or as a multipack of 10 individually packaged kits (item number 420910-10). The 9 mL SELPHYL® System contains 1 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing Calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™ access device, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BD Vacutainer® Blood transfer device.
Factor Medical, Inc.
PRFM
In Commercial Distribution

  • 30851802007091 ()
  • 10851802007097 ()
  • 10851802007004 ()

  • Total Volume: 9 Milliliter
420910

  • Haematological concentrate system preparation kit, platelet concentration

Thermo Scientific - 10850685007002

No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution

  • 10850685007002 ()
75007504

  • Cell washer IVD

Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
Not in Commercial Distribution

  • 10811877010347 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010323

Alere 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.
7D2649
Not in Commercial Distribution

  • 10811877010323 ()


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

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010293

Alere 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
Not in Commercial Distribution

  • 10811877010293 ()


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

IH-AbID - 03610522136421

IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD

IH-Com V5.2 - 03610522123919

IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD

IH-Card ABO Neutral - 03610522055685

The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Bio-Rad Medical Diagnostics GmbH
12008722
In Commercial Distribution

  • 03610522055685 ()
12008722

  • Column agglutination IVD

IH-Com - 03610520569870

IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution

  • 03610520569870 ()
009100

  • Laboratory instrument/analyser application software IVD

Geenius - 03610520013854

Geenius HIV 1/2 Controls
BIO-RAD
72339
In Commercial Distribution

  • 03610520013854 ()


  • HIV1/HIV2 antibody IVD, control

Geenius - 03610520013847

Geenius HIV 1/2 Supplemental assay
BIO-RAD
72461
In Commercial Distribution

  • 03610520013847 ()
72461

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

ePROGESA - 03665324000050

No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system

ePROGESA - 03665324000036

No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system

Patient Health Software (P.H.S) - 03665324000005

No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system

Eurotrol - 08718734960409

Assayed Quality control solution
Eurotrol B.V.
188.003.002
In Commercial Distribution

  • 08718734960409 ()
  • 08718734960416 ()
188.003.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960386

Assayed Quality control solution
Eurotrol B.V.
188.002.002
In Commercial Distribution

  • 08718734960386 ()
  • 08718734960393 ()
188.002.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960362

Assayed Quality control solution
Eurotrol B.V.
188.001.002
In Commercial Distribution

  • 08718734960362 ()
  • 08718734960379 ()
188.001.002

  • Total haemoglobin (totHb) IVD, control

MacoMix HM20 and Hemolog 6 - 03567051503227

The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the preset target volume has been reached.
MACO PHARMA
9HHM-020-F
In Commercial Distribution

  • 03567051503227 ()
9HHM-020-F

  • Blood donation rocker

MRV6000LD - Therapeutic Phlebotomy Bag w/Needle - 03567051503128

500 mL Phlebotomy Bag with Needle.
MACO PHARMA
MRV
Not in Commercial Distribution

  • 13567051503125 ()
  • 03567051503128 ()
MRV6000LD

  • Blood donor set, triple-pack

VSE4002XD - Empty Bag 600 mL - 03567051503111

600 mL Empty Bag.
MACO PHARMA
VSE
Not in Commercial Distribution

  • 13567051503118 ()
  • 03567051503111 ()
VSE4002XD

  • Blood donor set, single-pack

VSL7000YD - Therapeutic Phlebotomy Bag - 03567050070324

600 mL Phlebotomy Bag with Luer Lock.
MACO PHARMA
VSL
In Commercial Distribution

  • 13567050070321 ()
  • 03567050070324 ()
VSL7000YD

  • Blood donor set, single-pack

VSL7001PD - Therapeutic Phlebotomy Bag w/Needle - 03567050070317

600 mL Phlebotomy Bag with Needle.
MACO PHARMA
VSL
In Commercial Distribution

  • 13567050070314 ()
  • 03567050070317 ()
VSL7001PD

  • Blood donor set, single-pack

VQE2001XD - 4 Empty Bags 300 mL - 03567050069908

300ml Quad Splitting Empty Bags.
MACO PHARMA
VQE
In Commercial Distribution

  • 13567050069905 ()
  • 03567050069908 ()
VQE2001XD

  • Blood donor set, quad-pack

VSE8004XD - Empty Bag 600 mL 6-Way Man - 03567050069687

600 mL Empty Bag for Pooling of Blood Components.
MACO PHARMA
VSE
In Commercial Distribution

  • 13567050069684 ()
  • 03567050069687 ()
VSE8004XD

  • Blood donor set, single-pack

VSE3010XD - Empty Bag 300 mL 6-Way Man - 03567050052740

300 mL Empty Bag for Pooling of Blood Components.
MACO PHARMA
VSE
In Commercial Distribution

  • 13567050052747 ()
  • 03567050052740 ()
VSE3010XD

  • Blood donor set, single-pack

LCG2b with AS-1, AS-3 and AS-5 - 03567050035347

Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
MACO PHARMA
KSV
In Commercial Distribution

  • 13567050035344 ()
  • 03567050035347 ()
KSV0004XD

  • Blood donor set, single-pack

GeTraP - 08055271669762

GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTraP supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture.
KEDRION SPA
3.x.x.x
In Commercial Distribution

  • 08055271669762 ()


  • Blood bank information system application software

DUPLOCATH - 00085412600031

Catheter for the simultaneous application of Baxter two-component fibrin sealant in minimally invasive surgery. The application of Baxter's two-component fibrin sealant can be carried out via a double syringe system and the two-lumen Duplocath application catheter.
BAXTER INTERNATIONAL INC.
1506166
In Commercial Distribution

  • 50085412600036 ()
  • 00085412600031 ()
  • 20085412600035 ()

  • Length: 35 Centimeter
1506166

  • Open-surgery adhesive/sealant applicator, dual-channel

Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter - M5264C23041

For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set

Elecsys HIV combi PT - 04015630942497

HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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