MADSEN Astera 2

Basic Information

• Brand Name: MADSEN Astera 2
• Primary DI: 05713315007859
• Version / Model: 8-04-13104
• Catalog Number: 8-04-13104
• Company Name: Natus Medical Denmark ApS
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-12
• Public Version: 3
• Public Version Date: 2025-10-30
• Public Version Status: Update
• Public Device Record Key: 5a43e509-6ab0-403a-9173-de21746d0552

Device Description

1066 MADSEN Astera 2 with ACPDS, Including HB-7 Headset, Insert Phone and DD450

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: 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: 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41188	Speech audiometer	An electroacoustic device designed to measure the hearing threshold of a patient by presenting words of increasing or decreasing intensity through headphones, which the patient is required to recognize and repeat, to establish the hearing capacity of the patient and to determine if a hearing deficit exists.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315007859	GS1