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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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Clinisys SQ Blood Bank - B236SQBB202410

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
2024.1
In Commercial Distribution

  • B236SQBB202410 ()


  • Blood bank information system application software

Clinisys SQ Blood Bank - B236SQBB11030

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.3
In Commercial Distribution

  • B236SQBB11030 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB8230

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.2.3
Not in Commercial Distribution

  • B236BB8230 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB8130

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.1.3
Not in Commercial Distribution

  • B236BB8130 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB8010

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.0.1
Not in Commercial Distribution

  • B236BB8010 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB11020

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.2
Not in Commercial Distribution

  • B236BB11020 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB11010

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.1
Not in Commercial Distribution

  • B236BB11010 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB11000

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0
Not in Commercial Distribution

  • B236BB11000 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10110

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1.1
Not in Commercial Distribution

  • B236BB10110 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10100

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1
Not in Commercial Distribution

  • B236BB10100 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10010

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0.1
Not in Commercial Distribution

  • B236BB10010 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10000

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0
Not in Commercial Distribution

  • B236BB10000 ()


  • Blood bank information system application software

PreciControl Syphilis - 07613336183175

Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control

PreciControl Release Syphilis - 07613336183007

PreciControl Release Syphilis
Roche Diagnostics GmbH
09366903190
In Commercial Distribution

  • 07613336183007 ()
09366903190

  • Treponema pallidum total antibody IVD, control

PreciControl Release Anti-CMV - 07613336182987

No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control

Elecsys HIV combi PT - 07613336170212

No Description
Roche Diagnostics GmbH
08924180160
In Commercial Distribution

  • 07613336170212 ()
08924180160

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

Elecsys HIV combi PT - 07613336170182

No Description
Roche Diagnostics GmbH
08924163160
In Commercial Distribution

  • 07613336170182 ()
08924163160

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

BioAccess Marrow Collection System - M791MH21500

No Description
BIOACCESS INC
MH2150
In Commercial Distribution

  • M791MH21500 ()


  • Bone marrow collection/transfusion set

HIV-1 Standard Test System - M769HIVSTANDARD211

The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
Home Access Health Corporation
21
In Commercial Distribution

  • M769HIVSTANDARD211 ()


  • Capillary blood collection set, home-use

Express HIV-1 Test System - M769HIVEXPRESS201

The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use

Intra-Lock - D742BVBCTP250

L-PRF Red Cap Blood Collection CAT Tube (9 ml)
INTRA-LOCK INTERNATIONAL, INC.
BVBCTP2_50
In Commercial Distribution

  • D742BVBCTP250 ()
BVBCTP2_50

  • Blood collection set, noninvasive

IntraSpin - D742BTUBEHOLD1

IntraSpin Tube Holder Replacement
INTRA-LOCK INTERNATIONAL, INC.
BTUBEHOLD
In Commercial Distribution

  • D742BTUBEHOLD1 ()
BTUBEHOLD

  • Haematological concentrate system

IntraSpin - D742BROTOR1

IntraSpin Rotor, 110v & 220v
INTRA-LOCK INTERNATIONAL, INC.
BROTOR
In Commercial Distribution

  • D742BROTOR1 ()
BROTOR

  • Haematological concentrate system

IntraSpin - D742BPOWER2201

IntraSpin Power Cord, 220v
INTRA-LOCK INTERNATIONAL, INC.
BPOWER220
In Commercial Distribution

  • D742BPOWER2201 ()
BPOWER220

  • Haematological concentrate system

IntraSpin - D742BPOWER1101

IntraSpin Power Cord, 110v
INTRA-LOCK INTERNATIONAL, INC.
BPOWER110
In Commercial Distribution

  • D742BPOWER1101 ()
BPOWER110

  • Haematological concentrate system

IntraSpin - D742BHEX1

IntraSpin Hex Key, 110v & 220v
INTRA-LOCK INTERNATIONAL, INC.
BHEX
In Commercial Distribution

  • D742BHEX1 ()
BHEX

  • Haematological concentrate system

IntraSpin - D742BFUSE2201

IntraSpin Fuse, IS220
INTRA-LOCK INTERNATIONAL, INC.
BFUSE220
In Commercial Distribution

  • D742BFUSE2201 ()
BFUSE220

  • Haematological concentrate system

IntraSpin - D742BFUSE1101

IntraSpin Fuse, IS110
INTRA-LOCK INTERNATIONAL, INC.
BFUSE110
In Commercial Distribution

  • D742BFUSE1101 ()
BFUSE110

  • Haematological concentrate system

Intra-Lock - D742WCT50

L-PRF White Cap Plain Z Tube (9 ml)
INTRA-LOCK INTERNATIONAL, INC.
WCT_50
In Commercial Distribution

  • D742WCT50 ()
WCT_50

  • Blood collection set, noninvasive

IntraSpin - D742ISS2200

IntraSpin System Single 220 volts
INTRA-LOCK INTERNATIONAL, INC.
ISS220
In Commercial Distribution

  • D742ISS2200 ()
ISS220

  • Haematological concentrate system

IntraSpin - D742ISS1100

IntraSpin System Single 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISS110
In Commercial Distribution

  • D742ISS1100 ()
ISS110

  • Haematological concentrate system

IntraSpin - D742ISD2200

IntraSpin System Dual 220 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD220
In Commercial Distribution

  • D742ISD2200 ()
ISD220

  • Haematological concentrate system

IntraSpin - D742ISD1100

IntraSpin System Dual 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD110
In Commercial Distribution

  • D742ISD1100 ()
ISD110

  • Haematological concentrate system

IntraSpin - D742IS2200

IntraSpin 220 volts
INTRA-LOCK INTERNATIONAL, INC.
IS220
In Commercial Distribution

  • D742IS2200 ()
IS220

  • Haematological concentrate system

IntraSpin - D742IS1100

IntraSpin 110 volts
INTRA-LOCK INTERNATIONAL, INC.
IS110
In Commercial Distribution

  • D742IS1100 ()
IS110

  • Haematological concentrate system

StemTrol Control Cells - 15099590762896

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control

StemTrol Control Cells - 15099590220020

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632
In Commercial Distribution

  • 15099590220020 ()
IM3632

  • Fixative, Orth's solution

StemComp Reagent - 15099590220013

StemComp Reagent
Beckman Coulter, Inc.
IM3631
In Commercial Distribution

  • 15099590220013 ()
IM3631

  • Fixative, Orth's solution

LeukoTrol - 15099590639402

Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
PLT Control
In Commercial Distribution

  • 15099590639402 ()
175651

  • Full blood count IVD, control

LeukoTrol - 15099590639396

Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control
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