| Primary Device ID | 00816703024317 |
| NIH Device Record Key | 0f74d0d8-fb98-4047-a5c6-25042e05f17e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedSource Oxygen Regulator |
| Version Model Number | MS-010R15 |
| Catalog Number | Not Applicable |
| Company DUNS | 041674552 |
| Company Name | MEDSOURCE INTERNATIONAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816703024300 [Primary] |
| GS1 | 00816703024317 [Package] Contains: 00816703024300 Package: Case [20 Units] In Commercial Distribution |
| GS1 | 00840155411685 [Package] Contains: 00816703024300 Package: Box [1 Units] In Commercial Distribution |
| CAN | Regulator, Pressure, Gas Cylinder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-04 |
| Device Publish Date | 2021-04-26 |
| 00816703024362 | Oxygen Regulator, 0-25 LPM |
| 00816703024348 | Oxygen Regulator, Brass, 0-25 LPM |
| 00816703024317 | Oxygen Regulator, Aluminum, 0-15 LPM |
| 00816703024447 | Oxygen Regulator, Brass, 0-25 LPM |
| 00816703024416 | D-TANK REGULATOR |