| Primary Device ID | M766AS0951CU0 |
| NIH Device Record Key | b7a2c675-cc23-4f92-96bc-cec380e9db09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle |
| Version Model Number | AS095-1CU |
| Company DUNS | 807537683 |
| Company Name | CAIRE 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M766AS0951CU0 [Primary] |
| CAW | Generator, Oxygen, Portable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-04-20 |
| Device Publish Date | 2016-01-01 |
| M766AS0951U0 | FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM, REFURBISHED |
| M766AS0951CU0 | FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM, REFURBISHED |
| M766AS0951010 | AS095-101 |
| M766AS09510 | FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM |
| M766AS0771010 | AS077-101 |