| Primary Device ID | 10841470104822 | 
| NIH Device Record Key | 5fd3bfd0-84bf-41df-ac67-d271ab62e0f6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VT Sure | 
| Version Model Number | 7154111 | 
| Company DUNS | 030619483 | 
| Company Name | PULMODYNE 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841470104825 [Primary] | 
| GS1 | 10841470104822 [Package] Contains: 00841470104825 Package: [8 Units] In Commercial Distribution | 
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-03-10 | 
| Device Publish Date | 2025-02-28 | 
| 10841470106017 | 7153131 | 
| 10841470106000 | 7153121 | 
| 10841470105997 | 7151131 | 
| 10841470105980 | 7152131 | 
| 00841470105976 | 7152121 | 
| 10841470105966 | 7151121 | 
| 10841470104969 | 7153111 | 
| 10841470104938 | 7152111 | 
| 10841470104822 | 7154111 | 
| 10841470104815 | 7151111 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VT SURE  79402703  not registered Live/Pending | Intersurgical Limited 2024-06-26 |