| Primary Device ID | 00811478011104 |
| NIH Device Record Key | 9c1f9711-0a6c-4057-ba18-f6b6c16e6914 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CADWELL FREEDOM-MEDIUM |
| Version Model Number | E1-CADF-M |
| Catalog Number | E1-CADF-M |
| Company DUNS | 186765806 |
| Company Name | ELECTRO-CAP INTERNATIONAL 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800 527-2193 |
| eci@electro-cap.com | |
| Phone | 800 527-2193 |
| eci@electro-cap.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811478011104 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 00811478010213 - NEEDLE/SYRINGE KIT - LARGE | 2020-12-16 |
| 00811478011883 - ELECTRO-GEL 16oz | 2018-10-22 |
| 00811478011890 - ELECTRO-GEL 32oz | 2018-10-22 |
| 00811478011906 - ELECTRO-GEL 128OZ | 2018-10-22 |
| 00811478011913 - ELECTRO-GEL 16OZ. BOXED | 2018-10-22 |
| 00811478011920 - ELECTRO-GEL 32 OZ. BOXED | 2018-10-22 |
| 00811478010008 - CAP W/AG/AGCL ELECTRODES | 2018-07-06 |
| 00811478010015 - SPECIAL CAP | 2018-07-06 |