LT100

GUDID 15415067042313

Mechanical Heart Valve Leaflet Tester

ST. JUDE MEDICAL, INC.

Heart valve prosthesis tester, single-use
Primary Device ID15415067042313
NIH Device Record Key9fde485c-a7a1-4f63-8495-26f2e7b19786
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLT100
Catalog NumberLT100
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS105415067004772 [Previous]
GS105415067042316 [Primary]
GS115415067042313 [Package]
Contains: 05415067042316
Package: [20 Units]
In Commercial Distribution

FDA Product Code

LXNPROBE, TEST, HEART-VALVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-29
Device Publish Date2023-05-19

Devices Manufactured by ST. JUDE MEDICAL, INC.

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05415067042934 - Regent™2025-01-20 Mechanical Heart Valve
05415067042958 - Regent™2025-01-20 Mechanical Heart Valve
05415067042972 - Masters Series™2025-01-20 HP Mechanical Heart Valve
05415067043016 - Masters Series™2025-01-20 Mechanical Heart Valve
05415067043030 - Masters Series™2025-01-20 Mechanical Heart Valve

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