| Primary Device ID | 00816312024401 |
| NIH Device Record Key | 84a4b3df-8ad0-4917-9f8f-c51f9e270022 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RHYTHMLINK INTERNATIONAL, LLC |
| Version Model Number | RLSP533 |
| Company DUNS | 126290993 |
| Company Name | RHYTHMLINK INTERNATIONAL, LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816312024401 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-20 |
| Device Publish Date | 2022-01-12 |
| 00816312024401 | 23 Deep Cup Electrode Harness with multipin connector |
| 10816312023845 | Disposable Deep EEG Cup Electrodes |
| 00816312026733 | Concentric Needle Cable |
| 10816312027195 | 24 electrodes, 1.5m blue 13mm subdermal needles |
| 00816312027488 | 1 Bundle of 3 Quick Connect Arrays with 27 Deep Cups, 1.5m and 2 MR Sticky Pads, 2.5m |
| 00816312027600 | 27 Deep Cup Electrodes, 1.5m and 2 Ground Sticky Pads, 2.5m |