CORFLO

Basic Information

• Brand Name: CORFLO
• Primary DI: 10815149021703
• Version / Model: 31-5555
• Catalog Number: 31-5555
• Company Name: CORPAK MEDSYSTEMS, INC.
• Labeler DUNS: 147530323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 3
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: b8540660-9b3d-44d1-90e0-71b117ca6c47

Device Description

Stoma measuring Device for use with CORFLO cuBBy

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815149021700	GS1		5	In Commercial Distribution
Primary	10815149021703	GS1

Customer Contacts

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