| Primary Device ID | 10817183020360 |
| NIH Device Record Key | 36c3802f-0761-448c-9143-eac44f1ac1cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flo-Assist II |
| Version Model Number | 7-510-49 |
| Company DUNS | 627969264 |
| Company Name | NORTHGATE TECHNOLOGIES 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817183020363 [Primary] |
| GS1 | 10817183020360 [Package] Contains: 00817183020363 Package: [10 Units] In Commercial Distribution |
| LJH | System, Irrigation, Urological |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-10-14 |
| 00817183020820 - StimSite AM-VY1 Adapter | 2024-07-18 StimSite Voyant Adapter |
| 10817183020810 - PUREPNEUMO Tubing Set | 2024-07-17 Paired Insufflation and TAP Tubing |
| 00817183020769 - StimSite Signal Box | 2024-05-07 |
| 00817183020776 - StimSite Activation Card | 2023-11-29 Activation Card, StimSite, Single |
| 00817183020660 - NEBULAE SRS Tubing Set | 2023-02-22 |
| 00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump | 2023-02-22 |
| 00817183020745 - Smith & Nephew Insufflator 500 | 2021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM |
| 10817183020605 - TAP | 2021-01-13 Insufflation Tubing, True Abdominal Pressure Sensing |