| Primary Device ID | M68987220010 |
| NIH Device Record Key | 431bd9a6-53be-4bee-a144-690d59e6988f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Public Access Kit Individual |
| Version Model Number | 01 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |