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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
74400
In Commercial Distribution

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

  • Blood/tissue storage/culture container
No Description
BSL Co.,Ltd
ACPU-100
In Commercial Distribution

  • 08800080260026 ()
  • 08800080260019 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-SS-100
In Commercial Distribution

  • 08800080211028 ()
  • 08800080211011 ()
  • 08800080211035 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-40201
In Commercial Distribution

  • 08800080202224 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-24201
In Commercial Distribution

  • 08800080202217 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-6020
In Commercial Distribution

  • 08800080202200 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1240
In Commercial Distribution

  • 08800080202194 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2460
In Commercial Distribution

  • 08800080202187 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4001
In Commercial Distribution

  • 08800080202170 ()


  • Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2401
In Commercial Distribution

  • 08800080202163 ()


  • Autologous adipose tissue collection/injection set
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