Blue Elephant
GUDID 08800348920235
Blue Elephant Co.,Ltd.
Tinted non-prescription spectacles| Primary Device ID | 08800348920235 |
| NIH Device Record Key | b836de0b-a371-4f46-899f-4a094d42e17d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Elephant |
| Version Model Number | ANDY-S black-khaki tint |
| Company DUNS | 695736511 |
| Company Name | Blue Elephant Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800348920235 [Primary] |
FDA Product Code
| HQY | Sunglasses (Non-Prescription Including Photosensitive) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-30 |
| Device Publish Date | 2025-12-22 |
On-Brand Devices [Blue Elephant]
Trademark Results [Blue Elephant]
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.