| 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 |