RadioEar A/S

Basic Information

• Brand Name: RadioEar A/S
• Primary DI: 05711117228809
• Version / Model: DD65v2
• Company Name: Interacoustics A/S
• Labeler DUNS: 306308354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-12
• Public Version: 1
• Public Version Date: 2023-05-22
• Public Version Status: New
• Public Device Record Key: 25f7fe51-99c6-45ec-89d8-20823d29cbfa

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41240	Earphone, circumaural	An electroacoustic device intended to be worn around the ear to transmit sound to the ear from an external device for improved hearing or private listening. It has a cavity large enough to cover the external ear.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711117228809	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius