| Primary Device ID | 10860009331898 |
| NIH Device Record Key | 7943df9c-1661-48e0-b944-c3f858a2df36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXG Radiolucent Electrode System 4-Lead Electrode |
| Version Model Number | EXGEES4L |
| Catalog Number | EXGEES4L |
| Company DUNS | 080725301 |
| Company Name | CB Innovations, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com | |
| Phone | 7608002109 |
| info@cboothinnovations.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009331891 [Primary] |
| GS1 | 10860009331898 [Package] Contains: 00860009331891 Package: [20 Units] In Commercial Distribution |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| 00860009331808 - EXG Radiolucent Electrode System 12-Lead Electrode | 2026-03-17 The EXG Radiolucent Electrode System consists of a 12-Lead Electrode and an optional 3-Lead Posterior and Right Sided ECG Electr |
| 10860009331812 - EXG Radiolucent Electrode System 3-Lead Posterior Electrode | 2026-03-17 The EXG Radiolucent Electrode System consists of a 12-Lead Electrode and an optional 3-Lead Posterior and Right Sided ECG Electr |
| 10860009331898 - EXG Radiolucent Electrode System 4-Lead Electrode | 2026-03-17The EXG Radiolucent Electrode with 4-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is disposable, single use, and has been tested for up to 8-hour wear. It may be applied left arm to right arm, right chest to left abdomen, right chest to left chest, or right arm to left abdomen. |
| 10860009331898 - EXG Radiolucent Electrode System 4-Lead Electrode | 2026-03-17 The EXG Radiolucent Electrode with 4-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is d |
| 00860009331853 - EXG Radiolucent Electrode 5-Lead Cardiac Rhythm Electrode | 2026-03-13 The EXG Radiolucent Electrode with 5-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is d |