| Primary Device ID | 00840155402621 |
| NIH Device Record Key | 089b35ea-4081-43b6-8ea0-e1810bfb0d6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedSource Face Mask |
| Version Model Number | MS-12126 |
| Catalog Number | Not Applicable |
| Company DUNS | 041674552 |
| Company Name | MEDSOURCE INTERNATIONAL LLC |
| 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 | false |
| Manufacturing Date | false |
| 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 | 00840155402621 [Primary] |
| GS1 | 00840155402638 [Package] Package: Case [300 Units] In Commercial Distribution |
| QKR | Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
| 00840155402652 | Ear Loop Mask- Yellow |
| 00840155402621 | Ear Loop Mask- Blue |
| 00840155402591 | FFP2 Mask |
| 00816703024713 | Ear-Loop Mask |
| 00816703025901 | Face Mask, Padded, Adult, Ambu |
| 00816703025895 | Ventilation Mask Size 4 |
| 00816703025888 | Face Mask, Padded, Toddler, Ambu |
| 00816703025871 | Face Maks, Padded, Infant, Ambu |
| 00816703025864 | Face Mask, Padded, Neonatal, Ambu |