Advisor™ D-AVSE-DF10-F15

GUDID 05415067025975

Circular Mapping Catheter

ST. JUDE MEDICAL, INC.

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID05415067025975
NIH Device Record Key7ba53e34-47e0-4e18-b8ed-da8e6ef7edf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvisor™
Version Model NumberFL, Sensor Enabled™
Catalog NumberD-AVSE-DF10-F15
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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 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
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
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

Length115 Centimeter
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length115 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter
Catheter Gauge8 French
Length107 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored in a cool, dry location.
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067025975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2016-12-19

On-Brand Devices [Advisor™]

05415067025975Circular Mapping Catheter
05415067025968Circular Mapping Catheter
05415067024817Circular Mapping Catheter
05415067024800Circular Mapping Catheter
05415067031471Software Installation
05415067030092Catheter Catalog Installation

Trademark Results [Advisor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADVISOR
ADVISOR
90154450 not registered Live/Pending
Exactech, Inc.
2020-09-02
ADVISOR
ADVISOR
88905660 not registered Live/Pending
Mainstay Salire LLC
2020-05-07
ADVISOR
ADVISOR
87510531 5645555 Live/Registered
CircleBlack, Inc.
2017-06-29
ADVISOR
ADVISOR
87097093 5141515 Live/Registered
Serta, Inc.
2016-07-08
ADVISOR
ADVISOR
86815415 not registered Dead/Abandoned
MIRION TECHNOLOGIES (CANBERRA), INC
2015-11-10
ADVISOR
ADVISOR
86778826 5120636 Live/Registered
St. Jude Medical, Inc.
2015-10-05
ADVISOR
ADVISOR
86128899 not registered Dead/Abandoned
O & B Marketing, LLC
2013-11-25
ADVISOR
ADVISOR
86105817 not registered Dead/Abandoned
Tamarac Inc.
2013-10-30
ADVISOR
ADVISOR
85832556 4739520 Live/Registered
UTC Fire & Security Americas Corporation, Inc.
2013-01-25
ADVISOR
ADVISOR
85588655 not registered Dead/Abandoned
Illinois Tool Works, Inc.
2012-04-04
ADVISOR
ADVISOR
85293693 4107863 Dead/Cancelled
SHARECARE, INC.
2011-04-13
ADVISOR
ADVISOR
85282111 not registered Indifferent
Problem Knowledge Coupler Corporation
0000-00-00

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.