Biocor™ B100-23A-00
GUDID 05414734055383
ST. JUDE MEDICAL, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 05414734055383 |
| NIH Device Record Key | 085ba196-6a32-47b7-be51-984bdcacebf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biocor™ |
| Version Model Number | Aortic |
| Catalog Number | B100-23A-00 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
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 | |
| 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 Dimensions
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
| Outer Diameter | 23 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use. |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734055383 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P040021
FDA Product Code
| LWR | heart-valve, non-allograft tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Biocor™ ]
| 05414734055512 | Supra |
| 05414734055505 | Supra |
| 05414734055499 | Supra |
| 05414734055482 | Supra |
| 05414734055475 | Supra |
| 05414734055468 | Mitral |
| 05414734055451 | Mitral |
| 05414734055444 | Mitral |
| 05414734055437 | Aortic |
| 05414734055420 | Mitral |
| 05414734055413 | Aortic |
| 05414734055406 | Mitral |
| 05414734055390 | Aortic |
| 05414734055383 | Aortic |
| 05414734055376 | Aortic |
Trademark Results [Biocor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOCOR 85944010 not registered Dead/Abandoned |
Zoetis LLC 2013-05-28 |
 BIOCOR 79235903 not registered Live/Pending |
SICOR - SOCIEDADE INDUSTRIAL DE CORDOARIA, SA 2018-05-09 |
 BIOCOR 78946433 3690715 Live/Registered |
St. Jude Medical, Inc. 2006-08-07 |
 BIOCOR 78446881 3036817 Live/Registered |
Pin Link Industry Co., Ltd. 2004-07-07 |
 BIOCOR 77825481 not registered Dead/Abandoned |
Real Natural Remedies, LLC 2009-09-13 |
 BIOCOR 75166942 not registered Dead/Abandoned |
Biocor Industria e Pesquisas Ltda. 1996-09-16 |
 BIOCOR 74641918 2316862 Dead/Cancelled |
Minntech Corporation 1995-03-03 |
 BIOCOR 74246888 1756386 Dead/Cancelled |
BIOCOR ANIMAL HEALTH, INC. 1992-02-18 |
 BIOCOR 74246887 1769645 Dead/Cancelled |
Oxford Veterinary Laboratories, Inc. 1992-02-18 |
 BIOCOR 74216879 not registered Dead/Abandoned |
SmithKline Beecham Corporation 1991-10-24 |
 BIOCOR 73679427 1488053 Dead/Cancelled |
RICHARDSON-VICKS INC. 1987-08-19 |
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