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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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No Description
Luvo Medical Technologies Inc
WORLDPRP
In Commercial Distribution

  • 00754016214127 ()
  • 10754016214124 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system
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
The Grifols Diluent is for use in preparing human red blood cell suspensions and plasma/serum dilutions used with the DG Gel 8 cards. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
213677
In Commercial Distribution

  • 08437014205244 ()
  • 08437014205251 ()
213677

  • Wash/cleaning solution IVD, automated/semi-automated system
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD
DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
DIAGNOSTIC GRIFOLS SA
210363
In Commercial Distribution

  • 08437014205152 ()
210363

  • Gel column agglutination centrifuge IVD
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution

  • 08436583730980 ()
210404

  • Blood bank information system application software
AXP II Docking Station
Thermogenesis Corp.
80055
In Commercial Distribution

  • 00886368000667 ()
  • 10886368000664 ()
80055

  • Blood centrifugation system containment kit
AXP II Device
Thermogenesis Corp.
80056
In Commercial Distribution

  • 00886368000612 ()
  • 10886368000619 ()
80056

  • Blood centrifugation system containment kit
CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
73205
In Commercial Distribution

  • 04049934004841 ()
162-01

  • Magnetic cell separation system tubing set
CliniMACS® Tubing Set (TS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
73105
In Commercial Distribution

  • 04049934004834 ()
161-01

  • Magnetic cell separation system tubing set
CliniMACS® CD34 Reagent is a dark amber, non-viscous, colloidal solution containing an antibody conjugate in buffer. The conjugate consists of a murine IgG1 monoclonal antibody directed against the Class II epitope of the human CD34 antigen, which is chemically conjugated to dextran beads having an iron oxide/hydroxide core used in conjuction with the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
70103
In Commercial Distribution

  • 04049934004827 ()
171-01

  • Magnetic cell separation system reagent
CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
70026
In Commercial Distribution

  • 04049934004674 ()
  • 04049934001666 ()
700-25

  • Magnetic cell separation system buffered saline solution
The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
75101
In Commercial Distribution

  • 04049934004636 ()
151-01

  • Magnetic cell separation system processing unit
The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.
Miltenyi Biotec B.V. & Co. KG
74404
In Commercial Distribution

  • 04049934000317 ()
  • 04049934001345 ()
200-074-404

  • Blood/tissue storage/culture container
The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.
Miltenyi Biotec B.V. & Co. KG
74403
In Commercial Distribution

  • 04049934000300 ()
  • 04049934001352 ()
200-074-403

  • Blood/tissue storage/culture container
The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.
Miltenyi Biotec B.V. & Co. KG
74402
In Commercial Distribution

  • 04049934000294 ()
  • 04049934001369 ()
200-074-402

  • Blood/tissue storage/culture container
The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.
Miltenyi Biotec B.V. & Co. KG
74401
In Commercial Distribution

  • 04049934000287 ()
  • 04049934001376 ()
200-074-401

  • Blood/tissue storage/culture container
The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells.
Miltenyi Biotec B.V. & Co. KG
74400
In Commercial Distribution

  • 04049934000270 ()
  • 04049934001383 ()
200-074-400

  • Blood/tissue storage/culture container
LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution
Fresenius Kabi AG
4C4300
In Commercial Distribution

  • 14052682004305 ()
  • 04052682004308 ()
  • 00811137010486 ()
4C4300

  • Blood transfer set
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-0013-0264
In Commercial Distribution

900-001

  • Haemoglobin analyser IVD, point-of-care
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-0013-0264
In Commercial Distribution

  • 04048534001946 ()
900-001

  • Haemoglobin analyser IVD, point-of-care
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

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

  • 00810020442199 ()


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

  • 00810020441208 ()


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

  • 00810020441192 ()


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

  • 00810020440898 ()


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

  • 00810020440607 ()


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

  • 00810020440591 ()


  • Apheresis system
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