Primary Device ID | 00813880023102 |
NIH Device Record Key | 460d0f15-ab50-48dc-8bae-28c229113a23 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klear-Trace |
Version Model Number | 4800 |
Company DUNS | 078728314 |
Company Name | TRINITY MEDICAL DEVICES INC. |
Device Count | 3 |
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 | false |
Expiration Date | true |
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 | 00813880023102 [Primary] |
GS1 | 00813880023225 [Unit of Use] |
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-11-15 |
Device Publish Date | 2018-10-15 |
00813880023126 | Long Term 5 Lead Electrode |
00813880023119 | Long Term Infant/Pediatric Electrodes |
00813880023102 | Long Term Neonatal Electrodes |
00813880022174 | Short Term Neonatal/Infant Electrodes |
00813880027490 | Infant/Pediatric Electrodes |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KLEAR-TRACE 73763578 1641987 Live/Registered |
CAS MEDICAL SYSTEMS, INC. 1988-11-14 |