Primary Device ID | 00816394021688 |
NIH Device Record Key | 10fb54a7-883e-4e6d-8f2c-46e68937dc74 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | i.Series Platelet Incubator |
Version Model Number | PC2200-Pro |
Company DUNS | 086685682 |
Company Name | HELMER, 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 | 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 |