| Primary Device ID | B238H000107110 |
| NIH Device Record Key | 017c51b0-8db9-45f2-95fa-d72cc5d75662 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bowman Perfusion Monitor, 240V |
| Version Model Number | Model 500 |
| Catalog Number | H0001-0711 |
| Company DUNS | 128045676 |
| Company Name | HEMEDEX, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | B238H000107110 [Primary] |
| DPW | Flowmeter, Blood, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
| B238H000036110 - QFlow 500 2.7mm Drill Bit Kit | 2018-11-22 2.7mm Drill Bit Kit |
| B238H000036120 - QFlow 500 5.3mm Drill Bit Kit | 2018-11-22 5.3mm Drill Bit Kit |
| B238H000007100 - Bowman Perfusion Monitor, 120V | 2018-07-06 Perfusion Monitor, 120V |
| B238H000016000 - QFlow 500 Perfusion Probe | 2018-07-06 Thermal Diffusion Probe |
| B238H000036010 - QFlow 500 Titanium Bolt-Single Lumen | 2018-07-06 Intracranial Single Lumen Bolt |
| B238H000036020 - QFlow 500 Titanium Bolt-Dual Lumen | 2018-07-06 Intracranial dual lumen bolt |
| B238H000036310 - QFlow 500 Titanium Bolt-Single Lumen Bolt Kit | 2018-07-06 Intracranial Single Lumen Bolt Kit |
| B238H000036320 - QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit | 2018-07-06 Intracranial Dual Lumen Bolt Kit |