gudid
Primary ID: 74404
CryoMACS Freezing Bag 1000 (UDI 74404)
Manufactured by Miltenyi Biotec B.V. & Co. KG
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CryoMACS Freezing Bag 1000 - Primary ID 74404
Device Regulatory Overview
The CryoMACS Freezing Bag 1000 (Model/Catalog Number: 74404) is a medical device manufactured by Miltenyi Biotec B.V. & Co. KG. This product is indexed under FDA Product Code / Category Classification KSR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 74404
- Product Code / EMDN
- KSR
- Device Name
- The CryoMACS Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196C), and subsequent thawing (at 37C) 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 -196C), and subsequent thawing (at 37C) of hematopoietic progenitor cells.
- Database Sync Date
- 2026-08-09 09:11:21
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of CryoMACS Freezing Bag 1000?
The registered manufacturer of record for CryoMACS Freezing Bag 1000 is Miltenyi Biotec B.V. & Co. KG.
What is the Primary UDI-DI identifier for CryoMACS Freezing Bag 1000?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 74404.
What classification code is assigned to this device?
This device is registered under product classification code KSR.
Similar Classification Devices (KSR)
Other Devices by Miltenyi Biotec B.V. & Co. KG
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