| Primary Device ID | 05415067016669 | 
| NIH Device Record Key | 786ab752-8ae6-4360-b88e-ffa5c4ec50f7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cool Point™ | 
| Version Model Number | Irrigation Pump | 
| Catalog Number | H701666 | 
| Company DUNS | 926346966 | 
| Company Name | IRVINE BIOMEDICAL, 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 | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 | 
| customerservice@sjm.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05415067016669 [Primary] | 
| LPB | Cardiac ablation percutaneous catheter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-01-22 | 
| Device Publish Date | 2024-01-12 | 
| 05415067008985 | Irrigation Pump | 
| 05414734258616 | Irrigation Pump Tubing Set | 
| 05415067016669 | Pressure Alarm Adapter Cable | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  COOL POINT  85764606  not registered Dead/Abandoned | Shobick Innovation Systems 2012-10-26 | 
|  COOL POINT  76667938  3689713 Live/Registered | Irvine Biomedical, Inc. 2006-10-23 |