| Primary Device ID | 00860003624807 |
| NIH Device Record Key | f9d913fe-f9d0-45ee-82f7-24aedc76b014 |
| Commercial Distribution Discontinuation | 2029-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BYD CARE |
| Version Model Number | FF1311 |
| Catalog Number | FF1311 |
| Company DUNS | 545255648 |
| Company Name | BYD Precision Manufacture 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1(800)2932886 |
| byd.care@byd.com |
| Area/Surface Area | 25.77 Square inch |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT use if package is damaged. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003624807 [Primary] |
| QKR | Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-08 |
| Device Publish Date | 2020-03-31 |
| 00860003624807 | Single-use Face Mask Soft & Easy to Breath Use as Surgical Mask |
| 00860003645154 | N95 Health Care Particulate Respirator and Surgical Mask |
| 00850022724169 | BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili |
| 00850022724176 | BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BYD CARE 88981204 not registered Live/Pending |
BYD Company Ltd. 2020-03-19 |
![]() BYD CARE 88840620 not registered Live/Pending |
BYD Company Ltd. 2020-03-19 |