| Primary Device ID | 10841470107410 | 
| NIH Device Record Key | e5c17dd5-4774-40a5-a49e-0a744b33fbdb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AccuPAP | 
| Version Model Number | 301-6000 | 
| Company DUNS | 154502934 | 
| Company Name | ENGINEERED MEDICAL SYSTEMS INC | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841470107413 [Primary] | 
| GS1 | 10841470107410 [Package] Contains: 00841470107413 Package: [10 Units] In Commercial Distribution | 
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2019-11-11 | 
| Device Publish Date | 2018-08-24 | 
| 10841470108226 | 301-6003 | 
| 10841470108219 | 301-6002 | 
| 10841470107410 | 301-6000 | 
| 10841470107403 | 301-6001 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ACCUPAP  86033486  4633627 Live/Registered | Engineered Medical Systems, Inc. 2013-08-09 |