Primary Device ID | 00814112020128 |
NIH Device Record Key | 275157a2-13c2-46fd-8a5c-0aa4d50b6aeb |
Commercial Distribution Discontinuation | 2015-11-13 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | TandemHeart-TRIS |
Version Model Number | 5190-0015TRIS |
Company DUNS | 948683941 |
Company Name | CARDIACASSIST, 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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |