CORFLO cuBBy LPGD

Basic Information

• Brand Name: CORFLO cuBBy LPGD
• Primary DI: 10815149022434
• Version / Model: 55-1255
• Catalog Number: 55-1255
• Company Name: CORPAK MEDSYSTEMS, INC.
• Labeler DUNS: 147530323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-24
• Public Version: 3
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: d10f96e4-af1a-42e5-b05a-2b8c184c2d62

Device Description

Low profile gastrostomy device kit with ENFit Connectors

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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: Yes
• Sterilization Methods: Ethylene Oxide

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
Primary	10815149022434	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French
Length	5.5	Centimeter
Device Size Text, specify			12 FR (4mm) x 5.5cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No