Primary Device ID | 00860003586303 |
NIH Device Record Key | 21d60619-0779-4423-b0f4-1cfdc2206f14 |
Commercial Distribution Discontinuation | 2021-09-30 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Caption AI (Caption Guidance + Caption Interpretation) |
Version Model Number | 0.10, 0.11, 1.1, 1.2, 1.3, 1.4 |
Catalog Number | 511-00003 |
Company DUNS | 079192179 |
Company Name | CAPTION HEALTH, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |