Ameritus

Basic Information

• Brand Name: Ameritus
• Primary DI: 10817522012827
• Version / Model: ENF-Straw
• Catalog Number: ENF-Straw
• Company Name: KENTEC MEDICAL, INC.
• Labeler DUNS: 066175613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-13
• Public Version: 2
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 5ace88b0-3bf0-4cc4-aec2-80c0b5e95918

Device Description

Enfit syringe straw

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: Yes
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILC	Utensil, Eating	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62258	Oral/enteral syringe drawing-up straw	A flexible, blunt, tubular device intended to be connected to an oral/enteral syringe for the convenient transfer of fluids (e.g., dissolved medication, liquid nutrition) from an open container into the syringe prior to oral/enteral administration; it is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30817522012821	GS1	case	800	In Commercial Distribution
Primary	10817522012827	GS1
Package	20817522012824	GS1	box	100	In Commercial Distribution

Customer Contacts

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