| Primary Device ID | 00856233005158 |
| NIH Device Record Key | 865465ea-4f70-4f9f-9cd3-3f880ac36d19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tapsystem |
| Version Model Number | 2A re-man'd, unpackaged |
| Catalog Number | 8002A-9999 |
| 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 | false |
| Serial Number | true |
| 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 |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856233005158 [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 | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2015-07-22 |
| 00856233005158 | A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged |
| 00856233005073 | A cable used to connect a patient to a Model 2A pulse generator system for the treatment of card |
| 00856233005066 | A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit). |