SJM™ Masters Series HP 17AFHPJ-505

GUDID 05414734055215

Aortic HP FlexCuff Rotatable Mechanical Heart Valve

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID05414734055215
NIH Device Record Key8d59081c-ba04-432b-9840-b1fed17d5de6
Commercial Distribution Discontinuation2020-04-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSJM™ Masters Series HP
Version Model NumberAFHPJ-505
Catalog Number17AFHPJ-505
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 Datefalse
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

Device Dimensions

Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in cool, dry area until needed

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734055215 [Primary]

FDA Product Code

LWQHEART-VALVE, MECHANICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2014-09-23

On-Brand Devices [SJM™ Masters Series HP]

05414734055307Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734055284Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734055260Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734055246Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734055222Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734055215Aortic HP FlexCuff Rotatable Mechanical Heart Valve
05414734054201MHPJ-505
05414734054195MHPJ-505
05414734021159MHPJ-505
05414734021142MHPJ-505
05414734021135MHPJ-505
05414734009614AEHPJ-505
05414734009607AEHPJ-505
05414734009591AEHPJ-505
05414734009584AEHPJ-505
05414734006408AHPJ-505
05414734006293AHPJ-505
05414734006125AHPJ-505
05414734006002AHPJ-505
05414734005883AHPJ-505
05414734005821AHPJ-505
05414734005784AEHPJ-505

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