| Primary Device ID | 00802526563201 |
| NIH Device Record Key | 32e71cc3-aaa7-4fcf-93da-936eaa02f813 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Q-TRAK™ Subcutaneous Electrode |
| Version Model Number | 3400 |
| Company DUNS | 017134557 |
| Company Name | CAMERON HEALTH, INC. |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00802526563201 [Primary] |
| LWS | Implantable cardioverter defibrillator (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
| 00802526542206 - Q TECH | 2018-09-11 Programmer for the S-ICD® System |
| 00802526521300 - SQ-RX® PULSE GENERATOR | 2018-07-06 SQ-RX Pulse Generator |
| 00802526524806 - S-ICD® System Patient Screening Tool | 2018-07-06 Patient Screening Tool |
| 00802526531019 - The Q-GUIDE™ Electrode Insertion Tool | 2018-07-06 Electrode Insertion Tool |
| 00802526531033 - S-ICD® System Magnet | 2018-07-06 Magnet |
| 00802526542244 - Q-TECH™ | 2018-07-06 Power Supply for S-ICD Programmer 3200 |
| 00802526553707 - HP OFFICEJET 100 Mobile Printer | 2018-07-06 Printer |
| 00802526562808 - SQ-RX® PULSE GENERATOR | 2018-07-06 SQ-RX Pulse Generator |