| Primary Device ID | 20686864048071 |
| NIH Device Record Key | 25e26394-4bab-4f50-9022-7598668788ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDICOM SAFEMASK |
| Version Model Number | 2900 |
| Catalog Number | 2900 |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 10 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864048077 [Unit of Use] |
| GS1 | 10686864048074 [Primary] |
| GS1 | 20686864048071 [Package] Contains: 10686864048074 Package: Outer Case [6 Units] In Commercial Distribution |
| HOY | Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2019-01-16 |
| 20686864048071 | MEDICOM SAFEMASK PROTECTIVE EYEWEAR ANTIFOG |
| 20686864027137 | SAFEMASK CONE ALUMINIUM NOSE BLUE |
| 20686864010245 | SAFEMASK CONE ALUMINIUM NOSE PINK |
| 20686864008761 | SAFEMASK TIE ON BLUE |
| 20686864056922 | Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Large |
| 20686864056915 | Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Medium |
| 20686864056908 | Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Small |
| 20686864058223 | Medicom SafeMask Junior - Pediatric Procedure Earloop Face Masks - Recommended age 4 to 12 years |
| 00686864059578 | Medicom SafeMask ArchitectPro - Surgical/N95 Respirator - Sample pack |