Safire™ 402813

GUDID 05414734206044

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

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 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 ID05414734206044
NIH Device Record Key82f56f33-d4fb-456b-a511-3961674a0087
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafire™
Version Model Number402813
Catalog Number402813
Company DUNS040960379
Company NameST. JUDE MEDICAL CARDIOVASCULAR DIVISION
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
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
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 dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734206044 [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 Number3
Public Version Date2019-01-28
Device Publish Date2014-09-23

On-Brand Devices [Safire™]

05414734217446402570
05414734217439402569
05414734217422402554
05414734217415402553
05414734217385402550
05414734217378402549
05414734206082402817
05414734206075402816
05414734206068402815
05414734206051402814
05414734206044402813
05414734206037Bi-Directional Ablation Catheter
05414734206020402811
05414734206013402810
05414734206006402809
05414734205993402808
05414734205986402807
05414734205979402806

Trademark Results [Safire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAFIRE
SAFIRE
98297887 not registered Live/Pending
Verite Inc.
2023-12-04
SAFIRE
SAFIRE
97632176 not registered Live/Pending
SAFIRE TECHNOLOGY GROUP, INC.
2022-10-14
SAFIRE
SAFIRE
90899579 not registered Live/Pending
NZ Aerosports Holdings Limited
2021-08-24
SAFIRE
SAFIRE
90607333 not registered Live/Pending
J.M. Huber Corporation
2021-03-27
SAFIRE
SAFIRE
90607318 not registered Live/Pending
J.M. Huber Corporation
2021-03-27
SAFIRE
SAFIRE
88943333 not registered Live/Pending
Aureon Energy Ltd.
2020-06-02
SAFIRE
SAFIRE
88850301 not registered Live/Pending
Osborne Industries, Inc.
2020-03-27
SAFIRE
SAFIRE
88850263 not registered Live/Pending
Osborne Industries, Inc.
2020-03-27
SAFIRE
SAFIRE
86647969 not registered Dead/Abandoned
Safire Tire, Inc.
2015-06-01
SAFIRE
SAFIRE
86401741 4973934 Live/Registered
GE Infrastructure Sensing, Inc.
2014-09-22
SAFIRE
SAFIRE
86046556 not registered Dead/Abandoned
New Image Global, Inc.
2013-08-23
SAFIRE
SAFIRE
85497780 4281631 Live/Registered
St. Jude Medical, Atrial Fibrillation Division, Inc.
2011-12-16

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