SJM Regent™ AG-RHR
GUDID 05414734009256
ST. JUDE MEDICAL, INC.
Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use Heart valve prosthesis holder, single-use| Primary Device ID | 05414734009256 |
| NIH Device Record Key | 4c5ae453-9cf2-48c8-90c4-d61a23ece2f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM Regent™ |
| Version Model Number | Mechanical Heart Valve |
| Catalog Number | AG-RHR |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May store indefinitely. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734009256 [Primary] |
| GS1 | 05415067042279 [Primary] |
FDA Product Code
| DTJ | HOLDER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
[05414734009256]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-12-04 |
On-Brand Devices [SJM Regent™ ]
| 05414734009256 | Mechanical Heart Valve |
| 05414734006392 | AGN-751 |
| 05414734006385 | AGFN-756 |
| 05414734006279 | AGN-751 |
| 05414734006262 | AGFN-756 |
| 05414734006101 | AGN-751 |
| 05414734006095 | AGFN-756 |
| 05414734005982 | AGN-751 |
| 05414734005975 | AGFN-756 |
| 05414734005869 | AGN-751 |
| 05414734005852 | AGFN-756 |
Trademark Results [SJM Regent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SJM REGENT 76440706 2736360 Live/Registered |
St. Jude Medical, Inc. 2002-08-15 |
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