Model: 24070400
DI: 05708296435944
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
SW,FSW AUDIGY 3.3,UP2
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
204a21be-26c2-4a40-a9d6-99a9d3979c31
Distribution Status:
In Commercial Distribution
DUNS Number:
306179227
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05708296435944
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60211
Name: Audiometric/hearing device software
Definition:
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).
FDA Product Codes
OSM
Hearing Aid, Air-Conduction with Wireless Technology, Prescription