| Primary Device ID | 00385640000093 |
| NIH Device Record Key | b95fa713-1b2d-4ee1-980e-2a1686debc3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RhinoCath Nasal Suction |
| Version Model Number | SP-45000 |
| Catalog Number | SP-45000 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| 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 | 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 | 00385640000093 [Primary] |
| GS1 | 10385640000090 [Package] Package: Box [5 Units] In Commercial Distribution |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-09 |
| 00385640083935 - INSTRUSAFE | 2024-11-21 |
| 00385640083904 - INSTRUSAFE | 2024-11-20 |
| 00385640083911 - INSTRUSAFE | 2024-11-20 |
| 00385640083928 - INSTRUSAFE | 2024-11-20 |
| 00385640083881 - INSTRUSAFE | 2024-11-19 |
| 00385640083898 - INSTRUSAFE | 2024-11-19 |
| 00385640083874 - INSTRUSAFE | 2024-11-18 |
| 00385640083836 - INSTRUSAFE | 2024-11-15 |