| Primary Device ID | 08800332261030 |
| NIH Device Record Key | 8089c9e7-5f17-4471-91c8-bc2fcd60c773 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Elephant |
| Version Model Number | TIMMY ash brown |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08800332261030 [Primary] |
| HQZ | Frame, Spectacle |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |