Primary Device ID | B437129500 |
NIH Device Record Key | caf5377f-65f6-435e-8ead-5a9ebbf53bd7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Unetixs Vascular |
Version Model Number | Multilab 2000 Series 2 Revo |
Catalog Number | 12950-0000-01 |
Company DUNS | 625463146 |
Company Name | UNETIXS VASCULAR, 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 | false |
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 | B437129500 [Primary] |
JAF | Monitor, Ultrasonic, Nonfetal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-07 |
Device Publish Date | 2023-02-27 |
B437129500 | The Revo is intended for use as a non-invasive diagnostic device by trained medical personnel fo |
B4371199606 | The MultiLab Series 2 2CP is intended for use as a non-invasive diagnostic device by trained med |
B4371198605 | The MultiLab is intended for use as a non-invasive diagnostic device by trained medical personne |
B4371194904 | The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained med |