| Primary Device ID | 00850025200011 |
| NIH Device Record Key | 08668d4d-2c68-4576-b855-a9c4d1460e51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIME 1776 |
| Version Model Number | GFM12 |
| Company DUNS | 117707985 |
| Company Name | AIME USA LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com | |
| Phone | 430-264-3872 |
| support@aimeusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025200004 [Primary] |
| GS1 | 00850025200011 [Package] Contains: 00850025200004 Package: Carton [50 Units] In Commercial Distribution |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-01 |
| Device Publish Date | 2020-11-23 |
| 10850025200025 | Disposable 3-ply earloop procedure mask |
| 00850025200011 | Disposable 3-ply earloop procedure mask |