| Primary Device ID | 08600050265002 |
| NIH Device Record Key | dff0f894-de6e-4975-b1ef-a858eecdba6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KF94 PROTECTION MASKS |
| Version Model Number | 1 |
| Company DUNS | 555324651 |
| Company Name | SONG HONG GARMENT JOINT STOCK CO. |
| Device Count | 3 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005026500 [Primary] |
| GS1 | 08600050265002 [Unit of Use] |
| MSH | Respirator, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-18 |
| Device Publish Date | 2021-01-09 |
| 08600050265002 - KF94 PROTECTION MASKS | 2021-01-185-layer structure Smooth ear strap Skin-friendly no-woven fabric Protect from dust and sunlight Use when traveling to polluted areas, during times of bad air quality. |
| 08600050265002 - KF94 PROTECTION MASKS | 2021-01-18 5-layer structure Smooth ear strap Skin-friendly no-woven fabric Protect from dust and sunlight Use when traveling to polluted |
| 08600050265170 - KF94 MEDICAL MASKS | 2021-01-18 5-layer structure Prevention of respiratory infections and ultra-fine dust 2.5 PM. Electrostatic filtration technology helps to |