FDA UDI
In Commercial Distribution
🇺🇸 United States
bebird
DI: 00850030574060
·
Model: W3-WM-BK
·
Be Bird Usa, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- bebird
- Primary DI
- 00850030574060
- Version / Model
- W3-WM-BK
- Catalog Number
- HVRS
- Company Name
- Be Bird Usa, Inc
- Labeler DUNS
- 117929555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-20
- Public Version
- 1
- Public Version Date
- 2021-08-30
- Public Version Status
- New
- Public Device Record Key
- ce85f8b4-22d6-49b5-a3e9-6f9be06dc40c
Device Description
Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wireless connects to your apple or android phone or tablet allowing the user to see high resolution images of their outer ear canal.
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
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44929 | Otoscope, endoscopic | An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850030574060 | GS1 |