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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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GS - 00847865013208

GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26222
In Commercial Distribution

  • 00847865013208 ()

  • Total Volume: 1.5 Milliliter
26222

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865013192

GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26221
In Commercial Distribution

  • 00847865013192 ()

  • Total Volume: 1.5 Milliliter
26221

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865013185

GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
Bio-RAD Laboratories, Inc.
26220
In Commercial Distribution

  • 00847865013185 ()

  • Total Volume: 1.5 Milliliter
26220

  • HIV1/HIV2 antigen/antibody IVD, control

SampLok® Sampling Kit 16mL - 09555240405616

SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
ITL ASIA PACIFIC SDN. BHD.
A100756
In Commercial Distribution

  • 19555240405613 ()
  • 09555240405616 ()
A100756

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 35mL - 09555240403865

SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100752
Not in Commercial Distribution

  • 19555240403862 ()
  • 09555240403865 ()
A100752

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 10mL - 09555240400734

SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100750
In Commercial Distribution

  • 19555240400731 ()
  • 09555240400734 ()
A100750

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 16mL - 09555240400536

SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100740
In Commercial Distribution

  • 19555240400533 ()
  • 09555240400536 ()
A100740

  • Blood/blood culture specimen transfer spike IVD, manual

ALBAcyte IgG Sensitized Red Blood Cells - 05060242471162

ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control

Ultra Transfusion Medicine - 05060508820031

Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution

  • 05060508820031 ()


  • Blood bank information system application software

Ortho Connect - 05060496770066

ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution

  • 05060496770066 ()


  • Laboratory instrument/analyser application software IVD

Sanguin Liberty SRIMPORT - 05060496770059

The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution

  • 05060496770059 ()


  • Blood bank information system application software

ORTHO CONNECT - 05060496770028

ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results of testing, assigns outcomes to individual samples according to a configured rule, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution

  • 05060496770028 ()


  • Blood bank information system application software

Procleix NAT Manager - 05060496770011

Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution

  • 05060496770011 ()


  • Blood bank information system application software

cobas Synergy - 05060496770004

cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution

  • 05060496770004 ()


  • Blood bank information system application software

Puriblood - 04719878520515

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-08-PS
In Commercial Distribution

  • 14719878520512 ()
  • 04719878520515 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520508

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-07-PS
In Commercial Distribution

  • 14719878520505 ()
  • 04719878520508 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520492

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-06-PS
In Commercial Distribution

  • 14719878520499 ()
  • 04719878520492 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520485

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-05-PS
In Commercial Distribution

  • 14719878520482 ()
  • 04719878520485 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520478

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-04-PS
In Commercial Distribution

  • 14719878520475 ()
  • 04719878520478 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520461

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-01-PS
In Commercial Distribution

  • 14719878520468 ()
  • 04719878520461 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520003

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-12-PS
In Commercial Distribution

  • 04719878520003 ()
  • 14719878520000 ()


  • Blood transfusion set, non-exchange

Virtue CPKit - 04719875912177

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912177 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912160

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912160 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912153

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912153 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912146

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912146 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912139

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912139 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912122

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912122 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912054

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912054 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912047

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912047 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912030

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912030 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912023

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912023 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912016

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912016 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912009

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912009 ()


  • Haematological concentrate system preparation kit, platelet concentration

BioHorizons - 00847236016043

IntraSpin System 220V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF220
In Commercial Distribution

  • 00847236016043 ()


  • Haematological concentrate system

BioHorizons - 00847236016036

IntraSpin System 110V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF110
In Commercial Distribution

  • 00847236016036 ()


  • Haematological concentrate system

BioHorizons - 00847236015978

Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system

BioHorizons - 00847236015893

IntraSpin Tube Holder Replacement
BIOHORIZONS IMPLANT SYSTEMS, INC
BTUBEHOLDZ
In Commercial Distribution

  • 00847236015893 ()


  • Centrifuge bucket/tube holder

BioHorizons - 00847236015886

IntraSpin Rotor, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BROTORZ
In Commercial Distribution

  • 00847236015886 ()


  • Centrifuge rotor, ultracentrifuge

BioHorizons - 00847236015879

IntraSpin Power Cord, 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER220Z
In Commercial Distribution

  • 00847236015879 ()


  • Electrical mains power cable

BioHorizons - 00847236015862

IntraSpin Power Cord, 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER110Z
In Commercial Distribution

  • 00847236015862 ()


  • Electrical mains power cable

BioHorizons - 00847236015855

IntraSpin Hex Key, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BHEXZ
In Commercial Distribution

  • 00847236015855 ()


  • Haematological concentrate system

BioHorizons - 00847236015848

IntraSpin Fuse 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE220Z
In Commercial Distribution

  • 00847236015848 ()


  • Haematological concentrate system

BioHorizons - 00847236015831

IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution

  • 00847236015831 ()


  • Haematological concentrate system

BioHorizons - 00847236015824

IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution

  • 00847236015824 ()


  • Haematological concentrate system

BioHorizons - 00847236015817

IntraSpin Centrifuge, 110 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS110Z
In Commercial Distribution

  • 00847236015817 ()


  • Haematological concentrate system

TransCyte - 00618474000046

TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived

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
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