SafeStraw™ 2 Pack

Basic Information

• Brand Name: SafeStraw™ 2 Pack
• Primary DI: 00714646000866
• Version / Model: 205
• Catalog Number: 205
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 38eee2d7-8c73-4192-b4e7-00b0daa3b7d8

Device Description

SafeStraw™ 2 Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
38752	Assistive drinking straw	A tubular device designed to be used by a person with a disability to suck fluids or liquefied food from a container and into their mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10714646000863	GS1
Primary	00714646000866	GS1

Customer Contacts

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