FDA UDI In Commercial Distribution 🇺🇸 United States

JIUYEE, Smart Bluetooth Hearing Aid (ITE)

DI: 06975925880140 · Model: Air C2, Jade Gold · Hunan JIUYEE Medical Technology Co., Ltd
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
JIUYEE, Smart Bluetooth Hearing Aid (ITE)
Primary DI
06975925880140
Version / Model
Air C2, Jade Gold
Company Name
Hunan JIUYEE Medical Technology Co., Ltd
Labeler DUNS
699350218
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-30
Public Version
1
Public Version Date
2023-08-07
Public Version Status
New
Public Device Record Key
b49a00fa-3bc5-48e2-8cf8-a329ed4656bc

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
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
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription

GMDN Terms

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

Identifiers

Type ID
Package 16975925880147
Primary 06975925880140