| Primary Device ID | 00781963454023 |
| NIH Device Record Key | 91907f31-9200-464f-8c6b-f07954805d16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Splash Shield Lite |
| Version Model Number | 4540SBMU |
| Company DUNS | 077359201 |
| Company Name | BERKLEY MEDICAL RESOURCES, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00781963454023 [Primary] |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-05 |
| 00781963454221 | Sold as box of 40 |
| 00781963454115 | Sold as box of 40 |
| 00781963454108 | Sold as box of 40 |
| 00781963454078 | Sold as box of 40 |
| 00781963454023 | Sold as box of 40 |
| 00781963452227 | Sold as box of 20 |
| 10781963454228 | Sold as box of 200 |
| 10781963454112 | Sold as box of 200 |
| 10781963454105 | Sold as box of 200 |
| 10781963454075 | Sold as box of 200 |
| 10781963454020 | Sold as box of 200 |
| 10781963452224 | Sold as box of 200 |