| Primary Device ID | 10816312023845 |
| NIH Device Record Key | c4885ea2-3d72-486e-b2ff-8ea21d384173 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rhythmlink International, LLC |
| Version Model Number | DC1415 |
| Company DUNS | 126290993 |
| Company Name | RHYTHMLINK INTERNATIONAL, LLC |
| Device Count | 14 |
| 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 | 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 |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
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| Phone | 8666333754 |
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| Phone | 8666333754 |
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| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx | |
| Phone | 8666333754 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816312023848 [Unit of Use] |
| GS1 | 10816312023845 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-04-05 |
| Device Publish Date | 2019-08-05 |
| 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 |