| Primary Device ID | 10841470105348 | 
| NIH Device Record Key | 4a5ea56e-c226-46b5-82b0-96bf6129de6a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VentiSure2 | 
| Version Model Number | 301-5678 | 
| 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 | 
| Phone | 317-246-5500 | 
| info@engmedsys.com | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841470105341 [Primary] | 
| GS1 | 10841470105348 [Package] Contains: 00841470105341 Package: [16 Units] In Commercial Distribution | 
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2019-11-11 | 
| Device Publish Date | 2016-09-30 | 
| 10841470106956 | 301-5802 | 
| 10841470105430 | 301-5911 | 
| 10841470105423 | 301-5740 | 
| 00841470105419 | 301-5679 | 
| 10841470105409 | 301-5810 | 
| 00841470105396 | 301-5735 | 
| 10841470105386 | 301-5812 | 
| 10841470105379 | 301-5803 | 
| 10841470105362 | 301-5742 | 
| 10841470105355 | 301-5581 | 
| 10841470105348 | 301-5678 | 
| 10841470105331 | 301-5580 | 
| 10841470105324 | 301-5800 | 
| 10841470105317 | 301-5726 | 
| 10841470105300 | 301-5736 | 
| 10841470105294 | 301-5818 | 
| 10841470105287 | 301-5582 | 
| 10841470105270 | 301-5734 | 
| 10841470105263 | 301-5680 | 
| 10841470105256 | 301-5811 | 
| 10841470105249 | 301-5739 | 
| 10841470105232 | 301-5813 | 
| 10841470105225 | 301-5677 | 
| 10841470105218 | 301-5579 | 
| 10841470105195 | 301-5737 | 
| 10841470105201 | 301-5817 |