HeartLight 18-1342

GUDID 00868976000130

Balloon Fill Media

CARDIOFOCUS, INC.

Vascular balloon catheter fill-media
Primary Device ID00868976000130
NIH Device Record Key70f44d2c-d4ed-48c9-8cda-4d88faaa68e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartLight
Version Model Number18-1342
Catalog Number18-1342
Company DUNS068966261
Company NameCARDIOFOCUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(844)527-3723
Emailcustomerservice@cardiofocus.com

Device Dimensions

Total Volume95 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100868976000130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00868976000130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-15

On-Brand Devices [HeartLight]

00868976000178Endoscopic Ablation Catheter
00868976000161Endoscopic Ablation Console (JP)
00868976000154Laser Ablation Console
00868976000147Deflectable Sheath
00868976000130Balloon Fill Media
00868976000123Endoscope
00868976000116Endoscopic Ablation Console (EU)
00868976000109Laser Ablation Balloon Catheter

Trademark Results [HeartLight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTLIGHT
HEARTLIGHT
97358233 not registered Live/Pending
Heartlight Ministries
2022-04-12
HEARTLIGHT
HEARTLIGHT
90879928 not registered Live/Pending
HeartLight Center Inc.
2021-08-12
HEARTLIGHT
HEARTLIGHT
90603755 not registered Live/Pending
Affordable Funeral Services, LLC
2021-03-25
HEARTLIGHT
HEARTLIGHT
88574184 not registered Live/Pending
River Rock Endeavors LLC
2019-08-10
HEARTLIGHT
HEARTLIGHT
85293628 4195520 Live/Registered
CardioFocus, Inc.
2011-04-13
HEARTLIGHT
HEARTLIGHT
78981460 3975660 Dead/Cancelled
Corley, Carole
2004-12-23
HEARTLIGHT
HEARTLIGHT
78601788 3179452 Live/Registered
Heartlight, Inc.
2005-04-05
HEARTLIGHT
HEARTLIGHT
78542757 3681474 Dead/Cancelled
Corley, Carole
2005-01-05
HEARTLIGHT
HEARTLIGHT
75599515 not registered Dead/Abandoned
Jeffrey Burton Low
1998-12-04
HEARTLIGHT
HEARTLIGHT
75212029 2165347 Dead/Cancelled
Heartlight, Inc.
1996-12-11
HEARTLIGHT
HEARTLIGHT
74117920 not registered Dead/Abandoned
BARRON, THOMAS ARCHIBALD
1990-11-26
HEARTLIGHT
HEARTLIGHT
74117919 not registered Dead/Abandoned
BARRON, THOMAS ARCHIBALD
1990-11-26

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