| Primary Device ID | 00856233005134 |
| NIH Device Record Key | 042da5b8-97cf-4099-a8cb-27058c34c685 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Model 7A |
| Version Model Number | Right arm patient lead wire |
| Catalog Number | 8023 |
| Company DUNS | 800214827 |
| Company Name | CARDIOCOMMAND, 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 | 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 | (800) 231-6370 |
| cconley@CardioCommand.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856233005134 [Primary] |
| LPA | System, Esophageal Pacing |
| 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 | 2015-04-03 |
| 00856233005172 | Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed |
| 00856233005165 | Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed |
| 00856233005134 | Patient lead wire for use with the Model 7A stimulator; white, right arm. |
| 00856233005127 | Patient lead wire for use with the Model 7A stimulator; black, left arm. |
| 00856233005110 | Interface cable between 7A Stimulator and Model 3 preamplifier. |
| 00856233005103 | Instrument cable for 7A Stimulator or Model 3 preamp. |