Primary Device ID | 00850014861360 |
NIH Device Record Key | 9ebf51df-9146-4dea-bce3-3c305eae5b75 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) |
Version Model Number | TD-4289 |
Company DUNS | 085509873 |
Company Name | Hearts Bio, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |