NeoDevices, Inc.

Basic Information

• Brand Name: NeoDevices, Inc.
• Primary DI: 10816340022087
• Version / Model: ND60EOY
• Company Name: NEODEVICES INC
• Labeler DUNS: 189670230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: 2fac5271-a45f-4afb-a4aa-83beee791099

Device Description

60" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector

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: Yes
• 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
58891	Gastrostomy tube Y-piece connector	A connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. It has two resealable ports intended for flushing the line and/or administering medications without the need for tube disconnection or interruption of an enteral feed. It is typically made of plastic materials and is available in a range of sizes. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816340027778	GS1		50	In Commercial Distribution
Primary	10816340022087	GS1

Customer Contacts

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