Corning

Basic Information

• Brand Name: Corning
• Primary DI: H10832861
• Version / Model: 3286
• Catalog Number: 3286
• Company Name: Corning Incorporated
• Labeler DUNS: 001307735
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-15
• Public Version: 3
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 45a5759b-fe21-4385-9d5b-37c58de363e9
• Distribution End Date: 2023-11-08

Device Description

Corning E-Cube Culture System Kit containing tubings, fittings, filters, and base; without 10-layer CellCube Module, 1 per pack, 1 per case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJA	Flask, tissue culture	Hematology	864.2240	1

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	H10832863	HIBCC		1	Not in Commercial Distribution	2023-11-08
Primary	H10832861	HIBCC

Customer Contacts

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