ENFit Large Bore Straw

Basic Information

• Brand Name: ENFit Large Bore Straw
• Primary DI: 00350770000305
• Version / Model: PEXT-3STBNC
• Catalog Number: PEXT-3STBNC
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 3
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: e5a8bff5-5d27-4a8b-af7d-a52077aecb9d

Device Description

3" ENFit Straw Large Bore Sterile Purp

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: No
• 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
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
Primary	00350770000305	GS1
Package	20350770000309	GS1	CS	8	In Commercial Distribution

Customer Contacts

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