Primary Device ID | 05391521421012 |
NIH Device Record Key | 7e1a7306-3a70-4a60-9f41-9f8a4f404c27 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KC® 4 Delta |
Version Model Number | N04000 |
Company DUNS | 985039126 |
Company Name | TCOAG IRELAND LIMITED |
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 |
---|---|
GS1 | 05391521421012 [Primary] |
JPA | System, Multipurpose For In Vitro Coagulation Studies |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-12 |
15391521421286 - TriniLIZE™ Stabilyte tubes | 2019-07-19 |
15391521420470 - TriniCLOT Lupus Screen | 2019-07-08 |
15391521420487 - TriniCLOT Lupus Confirm | 2019-07-08 |
15391521420630 - TriniCHECK Level 1 | 2019-07-08 |
15391521420647 - TriniCHECK Level 2 | 2019-07-08 |
15391521420654 - TriniCHECK Level 3 | 2019-07-08 |
15391521421309 - DT Wash | 2019-07-08 |
15391521421729 - DT Fluid | 2019-07-08 |