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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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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
High Efficiency Post-Process Filter System for Leukocyte Removal From Red Cells
HAEMONETICS CORPORATION
BPFAPLUS
In Commercial Distribution

  • 10887691313940 ()
  • 30887691313944 ()


  • Blood transfusion filter
Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS
HAEMONETICS CORPORATION
732-82
In Commercial Distribution

  • 30887691310684 ()
  • 10887691310680 ()


  • Blood/tissue storage/culture container
Platelet Pool and Store Set with eBDS
HAEMONETICS CORPORATION
732-80
In Commercial Distribution

  • 30887691307882 ()
  • 10887691307888 ()


  • Blood/tissue storage/culture container
LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 mL Transfer Bag
HAEMONETICS CORPORATION
LRF6BLA
In Commercial Distribution

  • 30887691305796 ()
  • 10887691305792 ()


  • Blood transfusion filter
LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10BLA
In Commercial Distribution

  • 30887691305307 ()
  • 10887691305303 ()


  • Blood transfusion filter
Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter
HAEMONETICS CORPORATION
BPFBLA
In Commercial Distribution

  • 30887691304218 ()
  • 10887691304214 ()


  • Blood transfusion filter
Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port
HAEMONETICS CORPORATION
NEO1
In Commercial Distribution

  • 30887691003876 ()
  • 10887691003872 ()


  • Blood transfusion filter
BPF Leukocyte Reduction Filteration System
HAEMONETICS CORPORATION
BPFB
In Commercial Distribution

  • 30887691000752 ()
  • 10887691000758 ()


  • Blood transfusion filter
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