| 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 |
| B040ATR1 - AVATR Minimally Invasive Adult Retractor with Interchangeable Blades | 2024-09-05 Multipurpose retractor for minimally invasive use - Thorocotomy, Sternotomy, |
| B040ATRAR0 - AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes | 2024-09-05 Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy, |
| B040CSR1 - Child Curved Sternal Retractor with Blades Only | 2024-09-05 Child Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 15 to 45kg |
| B040CSRAR0 - Child Curved Sternal Retractor with Blades Only | 2024-09-05 Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg |
| B040MMX1 - MINIMAX Minimally Invasive Retractor | 2024-09-05 Multipurpose retractor for minimally invasive thoracic use |
| B040MMX1R0 - MINIMAX Minimally Invasive Retractor | 2024-09-05 Multipurpose retractor for minimally invasive thoracic use including radiolucent blades |
| B040NSR1 - Neonatal Curved Sternal Retractor with Blades Only | 2024-09-05 Neonatal Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 0.5 to 5kg |
| B040NSRAR0 - Neonatal Curved Sternal Retractor with Blades Only | 2024-09-05 Neonatal Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 0.5 to 5kg |