Reflexion HD™ D402864

GUDID 05414734217262

Cardiac mapping/radio-frequency ablation catheter, single-use

Primary Device ID	05414734217262
NIH Device Record Key	ad18ffc9-f00b-4a07-8dd5-2a9b22a36162
Commercial Distribution Status	In Commercial Distribution
Brand Name	Reflexion HD™
Version Model Number	D402864
Catalog Number	D402864
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	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

Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.

Device Issuing Agency	Device ID
GS1	05414734217262 [Primary]

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Steralize Prior To Use	false
Device Is Sterile	true

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
05415067051301 - NA	2025-08-25 ADAS 3D LV License Software License
05415067051318 - NA	2025-08-25 ADAS 3D LA License Temporary Software License
05415067051646 - EnSite™	2025-08-25 X EP System PFA ECG Signal Splitter

Mark Image Registration \| Serial	Company Trademark Application Date
REFLEXION HD 77308527 3640505 Live/Registered	St. Jude Medical, Atrial Fibrillation Division, Inc. 2007-10-19