ENFit NeoSecure Tip Cap

Basic Information

• Brand Name: ENFit NeoSecure Tip Cap
• Primary DI: 00350770000381
• Version / Model: PNS-TCNC
• Catalog Number: PNS-TCNC
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 600
• Record Status: Published
• Publish Date: 2021-04-29
• Public Version: 2
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: f8a2e87b-f89a-462f-9e03-0cf83d5027f8

Device Description

ENFit NeoSecure Tip Cap NonSterile Purp

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNR	Enteral Syringes with enteral specific connectors	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16617	Medicine bottle cap	A sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770000388	GS1	CS	16	In Commercial Distribution
Primary	00350770000381	GS1
Unit of Use	20350770000385	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152857	000