| Primary Device ID | B040CPIM26 |
| NIH Device Record Key | 16cbfb8a-6e04-478e-a283-1f2d09fa40d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heart Chill Cardiac & Phrenic Insulator |
| Version Model Number | CPI-M |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040CPIM15 [Primary] |
| HIBCC | B040CPIM26 [Package] Contains: B040CPIM15 Package: [1 Units] In Commercial Distribution |
| DWC | Controller, Temperature, Cardiopulmonary Bypass |
| 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 | 2017-02-01 |
| B040TF240 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF26 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF28 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF30 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF32 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF34 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF360 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |
| B040TF38 - TransForm McCarthy Annuloplasty Ring | 2024-12-31 Annuloplasty Ring |