CryoStore Freezing Bag

Basic Information

• Brand Name: CryoStore Freezing Bag
• Primary DI: 10816203024258
• Version / Model: CS250
• Catalog Number: CS250
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2025-06-18
• Public Version: 2
• Public Version Date: 2025-08-25
• Public Version Status: Update
• Public Device Record Key: ab11ede1-b5ad-4839-a2d3-c69e5aa6d506
• Distribution End Date: 2025-08-22

Device Description

CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	864.9100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816203024255	GS1	Carton	6	Not in Commercial Distribution	2025-08-22
Primary	10816203024258	GS1
Unit of Use	00816203024251	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK030036	0

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Blood/tissue storage/culture container
• Type: Special Storage Condition, Specify
• Special Conditions: Do not re-use
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Do not resterilize