| Primary Device ID | 00385640000529 |
| NIH Device Record Key | 7dc25187-c0ea-4011-accd-da27ce0dfd1b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VA-1120 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com | |
| Phone | 888-229-2875 |
| customerservice@summitmedicalusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640000529 [Primary] |
| JZF | Tube, Ear Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-12 |
| 00385640085304 - INSTRUSAFE | 2025-02-21 |
| 00385640085243 - INSTRUSAFE | 2025-02-20 |
| 00385640085250 - INSTRUSAFE | 2025-02-20 |
| 00385640085267 - INSTRUSAFE | 2025-02-20 |
| 00385640085274 - INSTRUSAFE | 2025-02-20 |
| 00385640085281 - INSTRUSAFE | 2025-02-20 |
| 00385640085298 - INSTRUSAFE | 2025-02-20 |
| 00385640085212 - INSTRUSAFE | 2025-02-19 |