NeoConnect Oral / Enteral Syringe, OTC

Basic Information

• Brand Name: NeoConnect Oral / Enteral Syringe, OTC
• Primary DI: 00817584013223
• Version / Model: Neo12
• Catalog Number: Neo12
• Company Name: NEOMED, INC.
• Labeler DUNS: 799772079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-06
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 3e95af9b-bfcc-40e6-b64a-4ea42aeabbf8

Device Description

12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
62001	ENFit oral/enteral syringe, reusable	A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817584013227	GS1	Shipper	16	In Commercial Distribution
Package	10817584013220	GS1	Case	15	In Commercial Distribution
Primary	00817584013223	GS1

Customer Contacts

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