| Primary Device ID | 00816312026849 |
| NIH Device Record Key | 5069906a-a0b1-4e7a-a5c7-fad8fbf9f346 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MRQD42415 |
| Version Model Number | MRQD42415 |
| Company DUNS | 126290993 |
| Company Name | RHYTHMLINK INTERNATIONAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816312026849 [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 | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
| 00816312027792 - Rhythmlink® | 2025-10-07 (14) MR Conditional Small Webb Electrodes, 1.5m |
| 10816312027805 - Rhythmlink® | 2025-10-02 (2) Array MR/CT Conditional Quick Connect, Small Webb, 1.5m [17 Pack] |
| 10816312027812 - Rhythmlink® | 2025-09-15 (3) Array MR/CT Conditional Quick Connect, 180mm Deep Cup, 1.5m (23 Pack) |
| 00816312027365 - Rhythmlink® | 2025-08-07 3 13mm Fixed Distance Guardian Needles & 2 13mm Guradian Needles w/1.5m Cable |
| 00816312027372 - Rhythmlink® | 2025-08-07 3 13mm Fixed Distance Guardian Needles & 2 13mm Guradian Needles Without Bandage w/1.5m Cable |
| 00816312027785 - Rhythmlink® | 2025-08-01 26 InvisaDeep Cup™ EEG Electrodes in 2 Bundles |
| 00816312027761 - Rhythmlink® | 2025-07-31 1 Bundle of 21 Disposable Deep EEG Cup Electrodes |
| 00816312027778 - Rhythmlink® | 2025-07-31 1 Bundle of 27 Disposable Deep EEG Cup Electrodes |