| Primary Device ID | 00816787020243 |
| NIH Device Record Key | 3b036c2e-4996-41bf-9f58-24e18011bcc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 811-B 24V SALES KIT W/901CC |
| Version Model Number | 811-B 24V 901CC |
| 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 | true |
| 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 |