| Primary Device ID | 05414734309929 | 
| NIH Device Record Key | 0407be8e-2dc5-492a-8ddd-13e6f17fdb92 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Inquiry™ | 
| Version Model Number | AFocus II™ | 
| Catalog Number | IBI-87008 | 
| 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 | 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 | 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 | |
| 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 | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 110 Centimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05414734309929 [Primary] | 
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2015-05-22 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  INQUIRY  86078860  not registered Dead/Abandoned | The Learning Internet, Inc. 2013-09-30 | 
|  INQUIRY  85580396  4233939 Live/Registered | St. Jude Medical, Atrial Fibrillation Division, Inc. 2012-03-26 | 
|  INQUIRY  76633860  3139673 Live/Registered | ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2005-03-21 | 
|  INQUIRY  74704302  not registered Dead/Abandoned | inquiry.com inc. 1995-07-20 | 
|  INQUIRY  74372483  1898366 Dead/Cancelled | PARSONS, McKEE, SOMMERS and COMPANY 1993-03-29 | 
|  INQUIRY  74356532  not registered Dead/Abandoned | PARSONS, McKEE, SOMMERS and COMPANY 1993-02-08 | 
|  INQUIRY  73353509  1246036 Dead/Cancelled | Inquiry 1982-03-08 | 
|  INQUIRY  73103554  1066987 Dead/Expired | INQUIRY 1976-10-18 | 
|  INQUIRY  72288934  0871806 Live/Registered | BLUE CROSS ASSOCIATION 1968-01-16 |