Cryostore

Basic Information

• Brand Name: Cryostore
• Primary DI: 10816203021066
• Version / Model: CS25XN
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: f03606d4-9566-4aeb-bc85-46b7b0f71681

Device Description

Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, 8" donor tube, case of 24

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	20816203021063	GS1	Case	6	In Commercial Distribution
Primary	10816203021066	GS1
Unit of Use	00816203021069	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK030036	0