FDA UDI In Commercial Distribution 🇺🇸 United States

Primus By Auditdata

DI: 05711781001685 · Model: 2000 Primus Fitting Unit + · Auditdata A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Primus By Auditdata
Primary DI
05711781001685
Version / Model
2000 Primus Fitting Unit +
Company Name
Auditdata A/S
Labeler DUNS
310385849
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-24
Public Version
3
Public Version Date
2023-11-17
Public Version Status
Update
Public Device Record Key
6472d374-0d17-446d-9564-c5cbb95c834d

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EWO Audiometer

GMDN Terms

Code Name
45241 Audiometric/hearing aid tester

Identifiers

Type ID
Primary 05711781001685