Grason & Associates, LLC

Basic Information

• Brand Name: Grason & Associates, LLC
• Primary DI: 00840162501447
• Version / Model: EC061
• Company Name: Grason & Associates LLC
• Labeler DUNS: 555553440
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 3ffceb4f-41a6-4fdf-8208-9733c5785fcb

Device Description

Earphone Cushion - Black, Single Pediatric

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	874.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31940	Earphone cushion	A device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840162501447	GS1