| Primary Device ID | 00816787020083 |
| NIH Device Record Key | fe7b5957-a322-494a-afa4-88beadb66407 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4B-SV CORDED REMOTE |
| Version Model Number | 300-0218-01 |
| Company DUNS | 009041773 |
| Company Name | PARKS MEDICAL ELECTRONICS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |