| Primary Device ID | 00886799001615 |
| NIH Device Record Key | 33b9b83b-472e-4553-b34f-08f86fa83e7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CDI™ Blood Parameter Monitoring System 500 |
| Version Model Number | 500A |
| Catalog Number | 500A |
| Company DUNS | 177655466 |
| Company Name | Terumo Cardiovascular Systems Corporation |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886799001615 [Primary] |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass |
| 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 |
| 00886799001738 | Interface cable for Jostra HL 20 |
| 00886799001646 | Monitor with two blood parameter modules and one H/S Probe. |
| 00886799001639 | Monitor with two blood parameter modules. |
| 00886799001622 | Monitor with one blood parameter module and one H/S Probe. |
| 00886799001615 | Monitor with one blood parameter module. |
| 00886799000410 | Interface cable for Meditronic Bio-Console 550 |
| 00886799000403 | Interface cable for TCVS Sarns Centrifugal Pump |
| 00886799000397 | Interface cable for TCVS Sarns 8000 |
| 00886799000007 | Calibrator, for use with the CDI Model 500 Monitor |