ThermoCool SF D131602

GUDID 10846835009323

BIOSENSE WEBSTER INC.

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 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 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 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 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 ID10846835009323
NIH Device Record Key21a24761-a93a-47fd-9421-05ec83e0e258
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoCool SF
Version Model NumberD131602
Catalog NumberD131602
Company DUNS020163218
Company NameBIOSENSE WEBSTER 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(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835009323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-28
Device Publish Date2014-09-10

On-Brand Devices [ThermoCool SF]

10846835009347D131604
10846835009330D131603
10846835009323D131602
10846835009316D131601
10846835002850BDI35JJRT
10846835002843BDI35FJRT
10846835002836BDI35FFRT
10846835002829BDI35DJRT
10846835002812BDI35DFRT
10846835002805BDI35DDRT
10846835002799BDI35BFRT
10846835002782BDI35BDRT
10846835002775BDI35BBRT

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