| Primary Device ID | 10841470104969 |
| NIH Device Record Key | 82ef38a7-8394-49f8-b531-1ac9230b4afe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VT Sure |
| Version Model Number | 7153111 |
| 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 | 00841470104962 [Primary] |
| GS1 | 10841470104969 [Package] Contains: 00841470104962 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 |