Miltenyi Biotec Inc

Matched from indexed company URL: MILTENYI BIOTEC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30033482833003348283Miltenyi Biotec Inc1Y2026-01-012303 Lindbergh St Auburn CA US 95602
30052900103004112148Miltenyi Biotec B. V. & Co. KG1N2026-01-01Friedrich-Ebert-Strasse 68 Bergisch Gladbach North Rhine-Westphalia DE D-51429
30082641303008264130Miltenyi Biotec B. V. & Co. KG Branch Teterow1N2026-01-01Robert-Koch-Strasse 1 Teterow Mecklenburg-Western Pomerania DE D-17166
30178128903017812890Miltenyi Biotec North America1Y2026-01-011201 Clopper Road Gaithersburg MD US 20878

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04049934000287CryoMACS® Freezing Bag 250 - 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.800-810-3135Regulatory_affairs_USA@milteny
04049934000287CryoMACS® Freezing Bag 250 - 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.800-810-3135Regulatory_affairs_USA@miltenyibiotec.com
04049934000294CryoMACS® Freezing Bag 500 - 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.800-810-3135Regulatory_affairs_USA@milteny
04049934000294CryoMACS® Freezing Bag 500 - 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.800-810-3135Regulatory_affairs_USA@miltenyibiotec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submission
1147971871719866BK090020
1257421871719866BK090020
1147971236898861BH110018
1257421236898861BH110018
1147971884933086
1257421884933086

PMN#

GUDID#

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