| Primary Device ID | 00840155407909 |
| NIH Device Record Key | 9285e6ec-aa87-4a9d-9e39-4cc39a3314c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedSource Face Shield |
| Version Model Number | MS-12100 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816703024652 [Primary] |
| GS1 | 00816703024669 [Package] Contains: 00816703024652 Package: Case [96 Units] In Commercial Distribution |
| GS1 | 00840155407909 [Package] Contains: 00816703024652 Package: Box [24 Units] In Commercial Distribution |
| KGB | Mask, Oxygen, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-07 |
| Device Publish Date | 2021-04-29 |
| 00840155401259 | Face Shield |
| 00840155400689 | Face Shield |
| 00840155407909 | Face Shield, Disposable |
| 00816703025857 | CPR Face Shield w/Pouch & Gloves |
| 00816703025833 | CPR Face Shield w/pouch |