FDA UDI In Commercial Distribution 🇺🇸 United States

Audio Service

DI: 05714880293760 · Model: KIT IF CIC Li 8.16 (US) · Ws Audiology Usa, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Audio Service
Primary DI
05714880293760
Version / Model
KIT IF CIC Li 8.16 (US)
Catalog Number
21054100
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-21
Public Version
1
Public Version Date
2026-01-29
Public Version Status
New
Public Device Record Key
1a32c3c1-e15a-425f-96fc-348d6c6af41f

Device Description

KIT IF CIC LI 8.16 (US) BL

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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription
KLW Masker, Tinnitus

GMDN Terms

Code Name
34672 Air-conduction hearing aid, in-the-ear

Identifiers

Type ID
Primary 05714880293760

Customer Contacts

Phone
17325626600