The Insides Neo

Basic Information

• Brand Name: The Insides Neo
• Primary DI: 09421905447195
• Version / Model: PS028
• Company Name: THE INSIDES COMPANY LIMITED
• Labeler DUNS: 594825946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-26
• Public Version: 1
• Public Version Date: 2023-06-05
• Public Version Status: New
• Public Device Record Key: 4732552d-a430-414b-837a-14aa1e8f0ce8

Device Description

The Insides Neo x1 Pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EXB	Collector, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64471	ENFit/ENFit linear connector	A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09421905447218	GS1	Carton	10	In Commercial Distribution
Primary	09421905447195	GS1
Package	09421905447201	GS1	Pouch - Sample	3	In Commercial Distribution