Corning

Basic Information

• Brand Name: Corning
• Primary DI: H108118011
• Version / Model: 11801
• Catalog Number: 11801
• Company Name: Corning Incorporated
• Labeler DUNS: 001307735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-02
• Public Version: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 5555dbd8-56ee-4ea6-ac42-646701cdcbb3

Device Description

Corning 850cm² Polystyrene Roller Bottle with 2 Port Cap, Tubing, Male Connector, Sterile 1/Bag, 2/Case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• 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
KJC	BOTTLE, ROLLER, 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	H108118013	HIBCC		2	In Commercial Distribution
Primary	H108118011	HIBCC

Customer Contacts

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