LT100

GUDID 15415067042313

Heart valve prosthesis tester, single-use

Primary Device ID	15415067042313
NIH Device Record Key	9fde485c-a7a1-4f63-8495-26f2e7b19786
Commercial Distribution Status	In Commercial Distribution
Version Model Number	LT100
Catalog Number	LT100
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	false
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

Device Issuing Agency	Device ID
GS1	05415067004772 [Previous]
GS1	05415067042316 [Primary]
GS1	15415067042313 [Package] Contains: 05415067042316 Package: [20 Units] In Commercial Distribution

LXN	PROBE, TEST, HEART-VALVE

Steralize Prior To Use	false
Device Is Sterile	true

05415067053343 - EnSite™	2025-09-12 X EP System OTA Certificate Software License
05415067001474 - WorkMate™ Unity™	2025-09-08 Module HL-7 Module
05415067001481 - WorkMate™ Unity™	2025-09-08 Module DICOM Module
05415067051226 - EnSite™	2025-08-25 X EP System Display Workstation
05415067051233 - NA	2025-08-25 ADAS 3D Base License Software License
05415067051257 - EnSite™	2025-08-25 X EP System Display Workstation
05415067051264 - NA	2025-08-25 ADAS 3D LA License Software License
05415067051295 - NA	2025-08-25 ADAS 3D LV License Temporary Software License