CryoStore

Basic Information

• Brand Name: CryoStore
• Primary DI: 10816203023749
• Version / Model: CS750KS
• Catalog Number: CS750KS
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-15
• Public Version: 1
• Public Version Date: 2023-03-23
• Public Version Status: New
• Public Device Record Key: 048a910b-0be4-46bf-a656-ca53a207f84a

Device Description

CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed

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	20816203023746	GS1	Case	12	In Commercial Distribution
Primary	10816203023749	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK030036	0