Primary Device ID | B238H000016000 |
NIH Device Record Key | 786891c5-b814-4095-b6f9-f42343660934 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | QFlow 500 Perfusion Probe |
Version Model Number | NA |
Catalog Number | H0000-1600 |
Company DUNS | 128045676 |
Company Name | HEMEDEX, INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
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 |
---|---|
HIBCC | B238H000016000 [Primary] |
DPW | Flowmeter, Blood, Cardiovascular |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B238H000016000]
Ethylene Oxide
[B238H000016000]
Ethylene Oxide
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 | 2018-07-06Thermal Diffusion Probe |
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 |