FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bose Frames
DI: 00017817820714
·
Model: BMD0011
·
BOSE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Bose Frames
- Primary DI
- 00017817820714
- Version / Model
- BMD0011
- Catalog Number
- 851336-0110
- Company Name
- BOSE CORPORATION
- Labeler DUNS
- 002579431
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 4
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- f0d9aabd-07b4-4f0e-9dbb-6d94aca5744b
- Distribution End Date
- 2023-12-31
Device Description
Soprano style prescription ready sunglasses.
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
- 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 |
|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 886.5850 | 1 |
| HQZ | Frame, Spectacle | Ophthalmic | 886.5842 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46297 | Tinted non-prescription spectacle lens | An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10017817820711 | GS1 | 8 | Not in Commercial Distribution | 2023-12-31 | |
| Primary | 00017817820714 | GS1 | ||||
| Package | 20017817820718 | GS1 | 20 | Not in Commercial Distribution | 2023-12-31 |
Customer Contacts
- Phone
- 1-877-230-5639
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius