CORFLO Jejunal Tube

Basic Information

• Brand Name: CORFLO Jejunal Tube
• Primary DI: 10815149020744
• Version / Model: 50-1438
• Catalog Number: 50-1438
• 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: 08d92d44-3f04-46cb-94b1-4321c861d063

Device Description

Jejunal tube with ENFit connectors over the wire for use with CORFLO PEG

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
38564	Jejunostomy tube	A sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815149020741	GS1		2	In Commercial Distribution
Primary	10815149020744	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 FR (2.7mm) X 43" (109cm)
Catheter Gauge	8	French
Length	43	Inch

Storage Conditions

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