| Primary Device ID | 00840155400443 |
| NIH Device Record Key | df6d5ace-2534-465f-a6c4-b2bedab21109 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedSource Oxygen Mask |
| Version Model Number | MS-26043-U |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840155400436 [Primary] |
| GS1 | 00840155400443 [Package] Contains: 00840155400436 Package: Case [50 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-05-28 |
| 00840155400443 | Oxygen Mask, Medium O2, Infant U. Conn. |
| 00840155400412 | Oxygen Mask, Medium O2, Pediatric |
| 00840155400405 | Oxygen Mask, Medium O2, Pediatric |
| 00840155400382 | Oxygen Mask, Medium O2, Elongated |
| 00840155411647 | "Medium Concentration Oxygen Mask Universal Connector, Pediatric " |