ENFit SIL Feeding Tube

Basic Information

• Brand Name: ENFit SIL Feeding Tube
• Primary DI: 00350770000862
• Version / Model: FTL8.0S-NC
• Catalog Number: FTL8.0S-NC
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 2
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: c9004a9d-7a4c-41e7-8cab-2453ba67ec0c

Device Description

ENFit SIL Feeding Tube Orange 8Fr 90cm

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPD	TUBE, FEEDING	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16798	Nasoenteral tube	A sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20350770000866	GS1	CS	16	In Commercial Distribution
Primary	00350770000862	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072881	000