Therapy™ IBI-84308

GUDID 05414734308564

IRVINE BIOMEDICAL, INC.

Cardiac mapping/radio-frequency ablation catheter, single-use Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter
Primary Device ID05414734308564
NIH Device Record Key6509099f-e4a2-440e-87aa-01a1890480c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTherapy™
Version Model NumberCool Path™
Catalog NumberIBI-84308
Company DUNS926346966
Company NameIRVINE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep cool, dry and away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734308564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-28
Device Publish Date2014-09-29

On-Brand Devices [Therapy™ ]

05415067019875Cool Path™
05415067004574Ablation Catheter
05415067004567Ablation Catheter
05415067004550Ablation Catheter
05415067004543Ablation Catheter
05414734310680Ablation Catheter
05414734310673Ablation Catheter
05414734310666Ablation Catheter
05414734310659Ablation Catheter
05414734308595Cool Path™
05414734308588Cool Path™
05414734308571Cool Path™
05414734308564Cool Path™
05414734308403IBI-83726
05414734308397Ablation Catheter
05414734308380IBI-83724
05414734308359Ablation Catheter
05414734308342IBI-83720
05414734308335IBI-83719
05414734307598IBI-83445
054147343075818mm Tip Thermistor Ablation Catheter
05414734307567IBI-83442
054147343075508mm Tip Thermistor Ablation Catheter
05414734307024Ablation Catheter
05414734307017Dual 8™
05414734307000Dual-8™
05414734306997Dual-8™
05414734306980Dual-8™
05414734306973Ablation Catheter
05414734306959IBI-83368
05414734306942Ablation Catheter
05414734306935IBI-83366
05414734306928IBI-83365
05414734306911IBI-83364
05414734306737Cool Path™
05414734306720Cool Path™
05414734306713Cool Path™
05414734306706Cool Path™

Trademark Results [Therapy]

Mark Image

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

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