FDA UDI In Commercial Distribution 🇺🇸 United States

CONNEXX

DI: 05714880187229 · Model: Connexx Fit2Go · Ws Audiology Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CONNEXX
Primary DI
05714880187229
Version / Model
Connexx Fit2Go
Catalog Number
21023158
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-17
Public Version
1
Public Version Date
2024-03-25
Public Version Status
New
Public Device Record Key
4b1bf3c9-ee6d-46aa-aa8c-6506cdbe6784

Device Description

APP CONNEXX FIT2GO

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

GMDN Terms

Code Name
60211 Audiometric/hearing device software

Identifiers

Type ID
Primary 05714880187229

Customer Contacts

Phone
17325626600