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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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Trima Accel® - 05020583810013

Automated Blood Collection System
TERUMO BCT, INC.
81001
In Commercial Distribution

  • 05020583810013 ()


  • Apheresis system

COBE® Spectra - 05020583719002

Refurbished COBE® Spectra Apheresis System
TERUMO BCT, INC.
71900
Not in Commercial Distribution

  • 05020583719002 ()


  • Blood transfer set

COBE® Spectra - 05020583711006

Single Needle Set
TERUMO BCT, INC.
71100
Not in Commercial Distribution

  • 05020583711006 ()


  • Blood transfer set

COBE® Spectra - 05020583706309

Bone Marrow Processing Set
TERUMO BCT, INC.
70630
In Commercial Distribution

  • 05020583706309 ()
  • 35020583706300 ()


  • Blood transfer set

COBE® Spectra - 05020583706293

White Blood Cell-Functionally Closed Tubing
TERUMO BCT, INC.
70629
Not in Commercial Distribution

  • 05020583706293 ()
  • 35020583706294 ()


  • Blood transfer set

COBE® Spectra - 05020583706200

White Blood Cell Set- Functionally Closed
TERUMO BCT, INC.
70620
In Commercial Distribution

  • 05020583706200 ()
  • 35020583706201 ()


  • Blood transfer set

COBE® Spectra - 05020583706101

Auto PBSC Set
TERUMO BCT, INC.
70610
In Commercial Distribution

  • 05020583706101 ()
  • 35020583706102 ()


  • Blood transfer set

COBE® Spectra - 05020583705005

Therapeutic Plasma Exchange Set
TERUMO BCT, INC.
70500
In Commercial Distribution

  • 05020583705005 ()
  • 35020583705006 ()
70500

  • Blood transfer set

TSCD®-II - 05020583620032

Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder
TERUMO BCT, INC.
62003
In Commercial Distribution

  • 05020583620032 ()


  • Package sealing unit

SCD®-IIB - 05020583620025

SCD®-IIB Sterile Tubing Welder
TERUMO BCT, INC.
62002
In Commercial Distribution

  • 05020583620025 ()


  • Package sealing unit

Trucise® 2.0 Total System - 05020583300088

Trucise 2.0 Communication Module
TERUMO BCT, INC.
METCM2
In Commercial Distribution

  • 05020583300088 ()


  • Blood bank information system

TSCD®-II - 05020583300064

3-Ncc947 Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC947
In Commercial Distribution

  • 05020583300064 ()


  • Package sealing unit

TSCD® - 05020583300040

Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC945
In Commercial Distribution

  • 05020583300040 ()


  • Package sealing unit

TSCD® II - 05020583300033

Sterile Tubing Welder
TERUMO BCT, INC.
3MESC203A
In Commercial Distribution

  • 05020583300033 ()


  • Package sealing unit

SCD® IIB - 05020583300026

SCD II Final Assembly
TERUMO BCT, INC.
3NCC986
In Commercial Distribution

  • 05020583300026 ()


  • Package sealing unit

TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE - 05020583114012

TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution

  • 05020583114012 ()
11401

  • Blood bank information system application software

Spectra Optia® - 05020583103009

IDL Set
TERUMO BCT, INC.
10300
In Commercial Distribution

  • 05020583103009 ()
  • 35020583103000 ()


  • Blood transfer set

Spectra Optia® - 05020583101104

Collection Set
TERUMO BCT, INC.
10110
In Commercial Distribution

  • 05020583101104 ()
  • 35020583101105 ()


  • Blood transfer set

HIV-1/2 Antibody Test Controls - 00628451188209

HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007590
In Commercial Distribution

  • 00628451188209 ()


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

Reveal G4 Rapid HIV-1/2 Antibody Test - 00628451188193

Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311000591
In Commercial Distribution

  • 00628451188193 ()


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

Reveal G4 Rapid HIV-1/2 Antibody Test - 00628451188186

Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007576
In Commercial Distribution

  • 00628451188186 ()


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

Reveal G4 Rapid HIV-1/2 Antibody Test - 00628451188179

Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007583
In Commercial Distribution

  • 00628451188179 ()


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

MicroAire® - 00847399017352

LIPOFILTER - CLINICAL PACK WITHOUT SYRINGE
Microaire Surgical Instruments LLC
ASP-CAN-NT
In Commercial Distribution

  • 00847399017352 ()


  • Liposuction system

MicroAire® - 00847399015884

LIPOFILTER - CLINICAL PACK
Microaire Surgical Instruments LLC
ASP-CAN-2S
In Commercial Distribution

  • 00847399015884 ()


  • Liposuction system

MicroAire® - 00847399006431

NEEDLE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-3
In Commercial Distribution

  • 00847399006431 ()


  • Collection syringe adaptor, single-use

MicroAire® - 00847399006424

SYRINGE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-2
In Commercial Distribution

  • 00847399006424 ()


  • Collection syringe adaptor, single-use

Atellica IM CHIV QC - 00630414598550

CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995528
In Commercial Distribution

  • 00630414598550 ()
10995528

  • HIV1/HIV2 antigen/antibody IVD, control

ADVIA Centaur® CHIV QC - 00630414590202

ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control

ADVIA Centaur® CHIV - 00630414589749

ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution

  • 00630414589749 ()
10696880

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

Chembio HIV 1/2 Stat-Pak Assay - 00607158000052

The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9505-1
In Commercial Distribution

  • 00607158000052 ()


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

Chembio DPP HIV 1/2 Rapid Test Control Pack - 00607158000045

The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9552-0
In Commercial Distribution

  • 00607158000045 ()


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

Clearview HIV Reactive/Nonreactive Controls - 00607158000038

The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control). One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9546-0
In Commercial Distribution

  • 00607158000038 ()


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

Clearview Complete HIV 1/2 - 00607158000021

The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution

  • 00607158000021 ()


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

Chembio DPP HIV 1/2 Assay - 00607158000007

The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution

  • 00607158000007 ()


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

DPP HIV-Syphilis - 00607158000083

The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.
Chembio Diagnostic Systems Inc.
65-9502-0
In Commercial Distribution

  • 00607158000083 ()


  • HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical

Chembio HIV Reactive/Nonreactive Controls - 00607158000076

The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control). One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9549-0
In Commercial Distribution

  • 00607158000076 ()


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

Fenwal Product Sample Pack - 14086000101421

For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution

  • 14086000101421 ()
  • 04086000101424 ()
  • 24086000101428 ()
4R2335H

  • Blood transfer set

PatientTouch Blood Product Administration - 00853209005006

The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
PATIENTSAFE SOLUTIONS, INC.
3.3.1
In Commercial Distribution

  • 00853209005006 ()
PTA BPA

  • Blood bank information system application software

Oracle Health Blood Bank - 00853023006173

No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2018
In Commercial Distribution

  • 00853023006173 ()


  • Blood bank information system application software

Oracle Health Transfusion Administration and Bridge Specimen Collection - 00853023006104

No Description
Cerner Corporation
Bridge2016
In Commercial Distribution

  • 00853023006104 ()


  • Blood bank information system application software
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