| Primary Device ID | 15414734011195 | 
| NIH Device Record Key | 5d0941c4-74cf-473c-a8df-b0c2858d7223 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ultimum™ | 
| Version Model Number | EV | 
| Catalog Number | 407650 | 
| 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 | 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 | 
| Length | 12 Centimeter | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Catheter Gauge | 7 French | 
| Length | 12 Centimeter | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Special Storage Condition, Specify | Between 0 and 0 * STORE IN A COOL, DARK, DRY PLACE. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05414734011198 [Primary] | 
| GS1 | 15414734011195 [Package] Contains: 05414734011198 Package: [10 Units] In Commercial Distribution | 
| DYB | INTRODUCER, CATHETER | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2019-06-07 | 
| Device Publish Date | 2015-08-31 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ULTIMUM  88775991  not registered Live/Pending | Meyer Manufacturing Company Limited 2020-01-28 | 
|  ULTIMUM  87701773  not registered Dead/Abandoned | Raynal Roberto Armando 2017-11-29 | 
|  ULTIMUM  87701711  not registered Dead/Abandoned | Armando Roberto Raynal 2017-11-29 | 
|  ULTIMUM  86951374  not registered Dead/Abandoned | Meyer Manufacturing Company Limited 2016-03-24 | 
|  ULTIMUM  85956500  4466327 Live/Registered | BEC Technologies, Inc 2013-06-11 | 
|  ULTIMUM  75271340  2290421 Dead/Cancelled | LEINER HEARLTH SERVICES CORP. 1997-04-08 |