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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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CryoMACS® Freezing Bag 500 - 04049934000294

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

CryoMACS® Freezing Bag 250 - 04049934000287

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

CryoMACS® Freezing Bag 50 - 04049934000270

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 - 04052682004308

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

DiaSpect Tm - 04048534002165

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

DiaSpect Tm - 04048534001946

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

Segment Sampler (SEG) - 19555240401332

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 Large Channel - 19555240400151

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 Small Channel - 19555240400137

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 - 00810020442199

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

  • 00810020442199 ()


  • Apheresis system

Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual - 00810020441642

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

Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual - 00810020441635

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

AMICUS Separator Legacy Software - 00810020441208

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

  • 00810020441208 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020441192

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

  • 00810020441192 ()


  • Apheresis system

PLASMACELL Xi Disposable Set with SPIKESMART - 00810020441116

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

Aurora Xi Plasmapheresis System - 00810020440898

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

  • 00810020440898 ()


  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike - 00810020440768

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

Plasmalink Transfer-Pack Container - 2000 mL - 00810020440669

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

AMICUS Separator Life Extension Software - 00810020440607

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

  • 00810020440607 ()


  • Apheresis system

AMICUS Separator Legacy Software - 00810020440591

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

  • 00810020440591 ()


  • Apheresis system

Aurora Xi - 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system

Aurora Software Version 2.1C Upgrade - 00810020440300

AURORA Software Version 2.1C for collection of plasma by membrane filtration.
Fresenius Kabi AG
Version 2.1C
In Commercial Distribution

  • 00810020440300 ()
  • 10810020440307 ()
X6S4021USB

  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike - 00810020440270

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
4R2358
In Commercial Distribution

  • 10810020440277 ()
  • 00810020440270 ()
4R2358

  • Apheresis system tubing set

AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440164

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353G
In Commercial Distribution

  • 10810020440161 ()
  • 00810020440164 ()
4R2353G

  • Apheresis system tubing set

AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

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

StemONE software - 15099590559519

stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD

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

Tropocells - 17290015874202

No Description
ESTAR TECHNOLOGIES LTD
06212SC
Not in Commercial Distribution

  • 17290015874202 ()
06212SC

  • Haematological concentrate system preparation kit, platelet concentration

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

PXP - 00886368001015

PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000155 ()
  • 00886368001015 ()


  • Blood centrifugation system containment kit

PXP - 00886368000971

PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000971 ()


  • Blood centrifugation system containment kit

PXP - 00886368000964

PXP Disposable Cartridge
Thermogenesis Corp.
80087
In Commercial Distribution

  • 00886368000155 ()
  • 00886368000964 ()


  • Blood centrifugation system containment kit

PXP - 00886368000711

PXP Disposable Cartridge
Thermogenesis Corp.
80063
In Commercial Distribution

  • 00886368000605 ()
  • 00886368000711 ()


  • Blood centrifugation system containment kit

PXP - 00886368000650

PXP Docking Station
Thermogenesis Corp.
80066
In Commercial Distribution

  • 00886368000643 ()
  • 00886368000650 ()


  • Blood centrifugation system containment kit

PXP - 00886368000636

PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit

AutoXpress Platform Counterbalance CG - 00886368000568

No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container

Thermogenesis Start Up Accessory Kit, AXP - 00886368000544

Thermogenesis Start Up Accessory Kit, AXP
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000544 ()


  • Blood centrifugation system containment kit

Component Retaining Clip Set, AXP - 00886368000537

AXP Accessory
Thermogenesis Corp.
8-5148
In Commercial Distribution

  • 00886368000537 ()
8-5148

  • Cryobiological storage container

Counterweight, AXP - 00886368000520

AXP Accessory
Thermogenesis Corp.
8-5104
In Commercial Distribution

  • 00886368000520 ()
8-5104

  • Cryobiological storage container

Xpresstrak Software Kit - 00886368000513

AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container

AXP Adapter Set, Sorvall 11754/11297 - 00886368000445

No Description
Thermogenesis Corp.
8-5114
In Commercial Distribution

  • 00886368000445 ()
8-5114

  • Cryobiological storage container

AXP Sorval 11754 Bucket Pads - 00886368000438

No Description
Thermogenesis Corp.
8-5155
In Commercial Distribution

  • 00886368000438 ()
8-5155

  • Cryobiological storage container

AXP Adapter, 101-102mm Round Bucket - 00886368000421

No Description
Thermogenesis Corp.
8-5113
In Commercial Distribution

  • 00886368000421 ()
8-5113

  • Cryobiological storage container

AXP Large Oval Bucket Adapter Set - 00886368000414

No Description
Thermogenesis Corp.
8-5112
In Commercial Distribution

  • 00886368000414 ()
8-5112

  • Cryobiological storage container

AXP Medium Oval Bucket Adapter Set - 00886368000407

No Description
Thermogenesis Corp.
8-5105
In Commercial Distribution

  • 00886368000407 ()
8-5105

  • Cryobiological storage container

AXP Start Up Accessory Kit - 00886368000377

Start-up kit for the AXP System
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000377 ()
8-5100

  • Cryobiological storage container
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