Corning

Basic Information

• Brand Name: Corning
• Primary DI: H1084313271
• Version / Model: 431327
• Catalog Number: 431327
• Company Name: Corning Incorporated
• Labeler DUNS: 001307735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 44047cdf-a2c8-44a6-aff1-49893ac898aa

Device Description

Corning® CellBIND® 1700cm² Expanded Surface Polystyrene Roller Bottle with Easy Grip Cap for Merck Serono, Sterile, 20/Bag, 20/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
Primary	H1084313271	HIBCC
Unit of Use	H1084313270	HIBCC
Package	H1084313273	HIBCC	Box	1	In Commercial Distribution

Customer Contacts

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