Primary Device ID | 00860001797961 |
NIH Device Record Key | 1f11066a-8e43-450f-a753-4d7aa1b042b8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OXY-1 System |
Version Model Number | Console Intake Filter, 5pk |
Catalog Number | 001-3300-039 |
Company DUNS | 079455574 |
Company Name | Breethe, Inc. |
Device Count | 5 |
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 | true |
Serial Number | false |
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 |