| Primary Device ID | 00860005054404 |
| NIH Device Record Key | 1b738b0d-849c-46d4-b46a-9264cf9e542b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONOPOWER FACE MASK |
| Version Model Number | 1 |
| Company DUNS | 557034526 |
| Company Name | MONOPOWER BIOPHARMACEUTICALS COMPANY LIMITED |
| Device Count | 50 |
| 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 | false |
| Manufacturing Date | true |
| 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 | 00860005054404 [Primary] |
| GS1 | 08600050544046 [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 | 2020-10-22 |
| Device Publish Date | 2020-10-14 |
| 00860005054404 - MONOPOWER FACE MASK | 2020-10-22Prevent dust and pollutants from the environment Standard quality of dust filter Soft elastic earloops for comfortable use. |
| 00860005054404 - MONOPOWER FACE MASK | 2020-10-22 Prevent dust and pollutants from the environment Standard quality of dust filter Soft elastic earloops for comfortable use. |
| 00860005054411 - MONOPOWER NITRILE GLOVES POWDER FREE | 2020-10-22 Non-Sterile/ Powder Free Ambidextrous Finger Tip Textured Beaded cuff Single use only |