Primary Device ID | 00860001797954 |
NIH Device Record Key | 7872eb1b-c96e-405b-9651-dec388bbc4ff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OXY-1 System |
Version Model Number | OXY-1 E-drive |
Catalog Number | 001-0901-003 |
Company DUNS | 079455574 |
Company Name | Breethe, 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 | 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 |