Cool Path™ A700244

GUDID 05415067002440

IRVINE BIOMEDICAL, INC.

Cardiac mapping/radio-frequency ablation catheter, single-use
Primary Device ID05415067002440
NIH Device Record Keyca1f18ef-bf82-4f94-8846-e91db7a84a7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCool Path™
Version Model NumberDuo, MediGuide Enabled™
Catalog NumberA700244
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

Device Dimensions

Catheter Gauge8 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067002440 [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 [Cool Path™ ]

05415067002440Duo, MediGuide Enabled™
05415067002433Duo, MediGuide Enabled™
05415067002426Duo, MediGuide Enabled™
05415067002419Duo, MediGuide Enabled™

Trademark Results [Cool Path]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COOL PATH
COOL PATH
85160408 3974533 Live/Registered
St. Jude Medical, Atrial Fibrillation Division, Inc.
2010-10-25

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