Response™ 401134

GUDID 05414734201209

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

Primary Device ID	05414734201209
NIH Device Record Key	a09a88e8-b804-4fea-a1c3-8e92e5cf159c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Response™
Version Model Number	CSL™
Catalog Number	401134
Company DUNS	040960379
Company Name	ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
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 AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE.

Device Issuing Agency	Device ID
GS1	05414734201209 [Primary]

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Steralize Prior To Use	false
Device Is Sterile	true

Mark Image Registration \| Serial	Company Trademark Application Date
RESPONSE 98264149 not registered Live/Pending	BISSELL Inc. 2023-11-10
RESPONSE 98058581 not registered Live/Pending	Alma Coffee Inc. 2023-06-26
RESPONSE 97776347 not registered Live/Pending	TECH FRIENDS, INC. 2023-02-01
RESPONSE 97608471 not registered Live/Pending	Crash Safety Solutions, LLC 2022-09-27
RESPONSE 97228980 not registered Live/Pending	American Automobile Association, Inc. 2022-01-20
RESPONSE 90520502 not registered Live/Pending	American Automobile Association, Inc. 2021-02-09
RESPONSE 90259719 not registered Live/Pending	American Automobile Association, Inc. 2020-10-16
RESPONSE 88898793 not registered Live/Pending	Response Inc. 2020-05-03
RESPONSE 88252048 not registered Dead/Abandoned	LabSolutions LLC 2019-01-07
RESPONSE 87861197 not registered Dead/Abandoned	Bee Sales Company 2018-04-03
RESPONSE 87861163 5610981 Live/Registered	Bee Sales Company 2018-04-03
RESPONSE 87673119 not registered Live/Pending	Precision Shooting Equipment, Inc. 2017-11-06