| Primary Device ID | 08600041033184 |
| NIH Device Record Key | 6da8fe9e-d191-4732-b6cd-85cc7bd87eac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PULSE QUALITY MASK |
| Version Model Number | 1 |
| Company DUNS | 557264015 |
| Company Name | IMPULSE FASHION VIETNAM GARMENT EXPORTING LIMITED COMPANY |
| Device Count | 2 |
| 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 | true |
| Serial Number | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004103318 [Primary] |
| GS1 | 08600041033184 [Unit of Use] |
| LYU | Accessory, Surgical Apparel |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
| 00860004103325 | Fabric mask washable up to 30x times Water Resistant Soft and Breathble Tripple Layer Protection |
| 08600041033184 | Fabric mask washable up to 30x times Water Resistant Soft and Breathable Tripple Layer Protectio |
| 00860004103301 | Fabric mask washable up to 30x times Water Resistant Soft and Breathable Tripple Layer Protectio |