Safire™ Duo MediGuide Enabled™ A700238

GUDID 05415067002389

IRVINE BIOMEDICAL, INC.

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 ID05415067002389
NIH Device Record Key27f97209-3ec2-4dca-ba93-01dc19b45f61
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafire™ Duo MediGuide Enabled™
Version Model NumberA700238
Catalog NumberA700238
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
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 Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location. Keep dry and keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067002389 [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 [Safire™ Duo MediGuide Enabled™]

05415067002402A700240
05415067002396A700239
05415067002389A700238
05415067002372A700237

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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