Philips

Basic Information

• Brand Name: Philips
• Primary DI: 05714464146222
• Version / Model: 274907
• Company Name: Sbo Hearing A/S
• Labeler DUNS: 306018410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-10
• Public Version: 1
• Public Version Date: 2025-02-18
• Public Version Status: New
• Public Device Record Key: 5d5eaacd-5944-4b75-8d4e-b9310cd66450

Device Description

PHILIPS HEARSUITE 2025.1 TRO

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
OSM	Hearing Aid, Air-Conduction with Wireless Technology, Prescription	Ear, Nose, Throat	874.3305	2
KLW	Masker, tinnitus	Ear, Nose, Throat	874.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05714464146222	GS1

Customer Contacts

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