| Primary Device ID | 10860011532788 |
| NIH Device Record Key | bd1c9ae5-76b6-406c-98a4-9936ad95bb28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORI Airways |
| Version Model Number | DM-4100-AF |
| Company DUNS | 129992866 |
| Company Name | Focal Point Logistics, LLC |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com | |
| Phone | 9726380496 |
| infofocalpoint@icloud.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011532781 [Primary] |
| GS1 | 10860011532788 [Package] Contains: 00860011532781 Package: [25 Units] In Commercial Distribution |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
| 10860011532795 | Sampling cannula, no oxygen delivery. |
| 10860011532788 | DM-4100-AF |
| 10860011532771 | DM-7700-ST |
| 10860011532764 | DM-7100/CO-8FTM |
| 10860011532757 | DM-4000-14FTAM |
| 10860011532740 | DM-4000-14FTAF |
| 10860011532733 | DM-4000-AF |
| 10860011532726 | DM-4000-10FTAF |
| 10860011532719 | DM-4000-AM |
| 10860011532702 | DM-4000-10FTAM |