NeoSeal®

Basic Information

• Brand Name: NeoSeal®
• Primary DI: 10812594012164
• Version / Model: Micro
• Catalog Number: N420
• Company Name: Neotech Products LLC
• Labeler DUNS: 198013435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2021-05-19
• Public Version: 4
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 960df08c-5b75-43f9-880b-1e20e36e612e

Device Description

The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
BXJ	Clip, Nose	Anesthesiology	868.6225	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64484	Patient tube cushion	A small patient-worn padding intended to function as a barrier between a patient tube/catheter (e.g., nasogastric tube, oxygen tube, surgical drain, laryngectomy or tracheostomy tube) and the skin to prevent irritation, maceration, and ulceration. It is typically made of a skin-friendly material (e.g., foam, silicone gel) designed to wrap/fit around the tube/catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00812594012167	GS1
Primary	10812594012164	GS1