| Primary Device ID | 05415067027764 | 
| NIH Device Record Key | 1d1ea6f2-8790-46c8-ba62-ac3ff885e89d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SJM™ | 
| Version Model Number | Monitor Cable | 
| Catalog Number | C12978 | 
| Company DUNS | 149818952 | 
| Company Name | ST. JUDE MEDICAL, 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 | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05415067027764 [Primary] | 
| NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-06-21 |