Biocor™ B100-25M-00

GUDID 05414734055406

ST. JUDE MEDICAL, INC.

Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis
Primary Device ID05414734055406
NIH Device Record Key97dd9e04-5bd3-4073-bd3c-fb603b87411b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiocor™
Version Model NumberMitral
Catalog NumberB100-25M-00
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. If temperature indicator is Red,do not use.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734055406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [Biocor™ ]

05414734055512Supra
05414734055505Supra
05414734055499Supra
05414734055482Supra
05414734055475Supra
05414734055468Mitral
05414734055451Mitral
05414734055444Mitral
05414734055437Aortic
05414734055420Mitral
05414734055413Aortic
05414734055406Mitral
05414734055390Aortic
05414734055383Aortic
05414734055376Aortic

Trademark Results [Biocor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOCOR
BIOCOR
85944010 not registered Dead/Abandoned
Zoetis LLC
2013-05-28
BIOCOR
BIOCOR
79235903 not registered Live/Pending
SICOR - SOCIEDADE INDUSTRIAL DE CORDOARIA, SA
2018-05-09
BIOCOR
BIOCOR
78946433 3690715 Live/Registered
St. Jude Medical, Inc.
2006-08-07
BIOCOR
BIOCOR
78446881 3036817 Live/Registered
Pin Link Industry Co., Ltd.
2004-07-07
BIOCOR
BIOCOR
77825481 not registered Dead/Abandoned
Real Natural Remedies, LLC
2009-09-13
BIOCOR
BIOCOR
75166942 not registered Dead/Abandoned
Biocor Industria e Pesquisas Ltda.
1996-09-16
BIOCOR
BIOCOR
74641918 2316862 Dead/Cancelled
Minntech Corporation
1995-03-03
BIOCOR
BIOCOR
74246888 1756386 Dead/Cancelled
BIOCOR ANIMAL HEALTH, INC.
1992-02-18
BIOCOR
BIOCOR
74246887 1769645 Dead/Cancelled
Oxford Veterinary Laboratories, Inc.
1992-02-18
BIOCOR
BIOCOR
74216879 not registered Dead/Abandoned
SmithKline Beecham Corporation
1991-10-24
BIOCOR
BIOCOR
73679427 1488053 Dead/Cancelled
RICHARDSON-VICKS INC.
1987-08-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.