| Primary Device ID | 05030267166145 |
| NIH Device Record Key | 1ad55f20-88d4-47ac-88ca-2fa9eb70f67c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTURI VALVE 28% OXYGEN, WHITE |
| Version Model Number | 1400028 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| 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 | 05030267166138 [Primary] |
| GS1 | 05030267166145 [Package] Contains: 05030267166138 Package: [50 Units] In Commercial Distribution |
| GS1 | 05030267166152 [Package] Contains: 05030267166138 Package: [200 Units] In Commercial Distribution |
| BYF | Mask, Oxygen, Low Concentration, Venturi |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-12 |
| Device Publish Date | 2024-04-04 |