Primary Device ID | 00860740002654 |
NIH Device Record Key | 0b7c41ba-f447-493d-a159-1ea320d85ca2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Provizio SEM Scanner Gateway |
Version Model Number | 02654 |
Company DUNS | 962732025 |
Company Name | Bruin Biometrics, LLC |
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 | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860740002654 [Primary] |
QEF | Pressure Ulcer Management Tool |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-06 |
Device Publish Date | 2022-06-28 |
00860740002616 - Provizio SEM Scanner | 2022-07-06 Provizio SEM Scanner - Integrated Sensor Head |
00860740002623 - Provizio SEM Scanner S | 2022-07-06 Provizio SEM Scanner S - Disposable Sensor - Manual PTID |
10860740002637 - Provizio SEM Scanner S Sensor | 2022-07-06 Provizio SEM Scanner S Sensor - Individual |
00860740002647 - Provizio SEM Scanner S | 2022-07-06 Provizio SEM Scanner S - Disposable Sensor Head |
00860740002654 - Provizio SEM Scanner Gateway | 2022-07-06Provizio SEM Scanner Gateway USB |
00860740002654 - Provizio SEM Scanner Gateway | 2022-07-06 Provizio SEM Scanner Gateway USB |
00860740002661 - Provizio SEM250 | 2022-07-06 Provizio SEM Scanner OEM Parts Kit |