Therapy™ IBI-84309

GUDID 05414734308571

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

Primary Device ID	05414734308571
NIH Device Record Key	550aeca2-c4c8-46be-8f6c-01b1e03fccd0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Therapy™
Version Model Number	Cool Path™
Catalog Number	IBI-84309
Company DUNS	926346966
Company Name	IRVINE BIOMEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep cool, dry and away from sunlight

Device Issuing Agency	Device ID
GS1	05414734308571 [Primary]

OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Steralize Prior To Use	false
Device Is Sterile	true

05415067019875	Cool Path™
05415067004574	Ablation Catheter
05415067004567	Ablation Catheter
05415067004550	Ablation Catheter
05415067004543	Ablation Catheter
05414734310680	Ablation Catheter
05414734310673	Ablation Catheter
05414734310666	Ablation Catheter
05414734310659	Ablation Catheter
05414734308595	Cool Path™
05414734308588	Cool Path™
05414734308571	Cool Path™
05414734308564	Cool Path™
05414734308403	IBI-83726
05414734308397	Ablation Catheter
05414734308380	IBI-83724
05414734308359	Ablation Catheter
05414734308342	IBI-83720
05414734308335	IBI-83719
05414734307598	IBI-83445
05414734307581	8mm Tip Thermistor Ablation Catheter
05414734307567	IBI-83442
05414734307550	8mm Tip Thermistor Ablation Catheter
05414734307024	Ablation Catheter
05414734307017	Dual 8™
05414734307000	Dual-8™
05414734306997	Dual-8™
05414734306980	Dual-8™
05414734306973	Ablation Catheter
05414734306959	IBI-83368
05414734306942	Ablation Catheter
05414734306935	IBI-83366
05414734306928	IBI-83365
05414734306911	IBI-83364
05414734306737	Cool Path™
05414734306720	Cool Path™
05414734306713	Cool Path™
05414734306706	Cool Path™

Mark Image Registration \| Serial	Company Trademark Application Date
THERAPY 97642023 not registered Live/Pending	TT IP, LLC 2022-10-21
THERAPY 97498619 not registered Live/Pending	NEW FIFTH MUSIC 2022-07-12
THERAPY 90787998 not registered Live/Pending	Therapy clothing L.L.C 2021-06-22
THERAPY 90100837 not registered Live/Pending	Therapy Skateboards, LLC 2020-08-07
THERAPY 88570181 not registered Live/Pending	Eco Touch, Inc. 2019-08-07
THERAPY 88468907 not registered Live/Pending	JGV Apparel Group, LLC 2019-06-11
THERAPY 88468896 not registered Live/Pending	JGV Apparel Group, LLC 2019-06-11
THERAPY 87631653 5538963 Live/Registered	Eco Touch, Inc. 2017-10-03
THERAPY 87379311 not registered Dead/Abandoned	Eco Touch, Inc. 2017-03-21
THERAPY 86844565 not registered Dead/Abandoned	LeClair, Jeff Robert 2015-12-10
THERAPY 86667060 5404129 Live/Registered	JGV APPAREL GROUP, LLC 2015-06-18
THERAPY 86595139 4858719 Live/Registered	EZRA ZION, LLC. 2015-04-13