Inquiry™ IBI-81603

GUDID 05414734305099

IRVINE BIOMEDICAL, INC.

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID05414734305099
NIH Device Record Key4db7797c-be1b-4b55-9eb3-14eb034050be
Commercial Distribution StatusIn Commercial Distribution
Brand NameInquiry™
Version Model NumberIBI-81603
Catalog NumberIBI-81603
Company DUNS926346966
Company NameIRVINE BIOMEDICAL, 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

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734305099 [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 Date2018-07-06
Device Publish Date2015-02-17

On-Brand Devices [Inquiry™]

05414734311489AFocusII™
05414734311434AFocusII™
05414734311427AFocusII™
05414734309929AFocus II™
05414734309912AFocus II™
05414734306362IBI-81947
05414734306348IBI-81945
05414734306294Luma-Cath™
05414734306249Luma-Cath™
05414734306218Luma-Cath™
05414734306201Luma-Cath™
05414734306041IBI-81872
05414734306034IBI-81871
05414734305976IBI-81809
05414734305969IBI-81807
05414734305945IBI-81802
05414734305938IBI-81801
05414734305891Optima™
05414734305846IBI-81762
05414734305686IBI-81736
05414734305679IBI-81735
05414734305662IBI-81734
05414734305624IBI-81730
05414734305600IBI-81721
05414734305587Optima™ PLUS
05414734305327Optima™
05414734305303Diagnostic Catheter
05414734305297Optima™
05414734305273AFocus II™
05414734305235AFocus™
05414734305228AFocus II™
05414734305174Optima™
05414734305150Diagnostic Catheter
05414734305099IBI-81603
05414734305051AFocus II™
05414734305020AFocus II™
05414734305013AFocus II™
05414734305006AFocus II™
05414734304986AFocusII™
05414734304962AFocus II™
05414734304900IBI-81557
05414734304887IBI-81543
05414734304870IBI-81542
05414734304856IBI-81540
05414734304825IBI-81537
05414734304801IBI-81534
05414734304795IBI-81532
05414734304788IBI-81531
05414734304771IBI-81530
05414734304733IBI-81526

Trademark Results [Inquiry]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INQUIRY
INQUIRY
86078860 not registered Dead/Abandoned
The Learning Internet, Inc.
2013-09-30
INQUIRY
INQUIRY
85580396 4233939 Live/Registered
St. Jude Medical, Atrial Fibrillation Division, Inc.
2012-03-26
INQUIRY
INQUIRY
76633860 3139673 Live/Registered
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.
2005-03-21
INQUIRY
INQUIRY
74704302 not registered Dead/Abandoned
inquiry.com inc.
1995-07-20
INQUIRY
INQUIRY
74372483 1898366 Dead/Cancelled
PARSONS, McKEE, SOMMERS and COMPANY
1993-03-29
INQUIRY
INQUIRY
74356532 not registered Dead/Abandoned
PARSONS, McKEE, SOMMERS and COMPANY
1993-02-08
INQUIRY
INQUIRY
73353509 1246036 Dead/Cancelled
Inquiry
1982-03-08
INQUIRY
INQUIRY
73103554 1066987 Dead/Expired
INQUIRY
1976-10-18
INQUIRY
INQUIRY
72288934 0871806 Live/Registered
BLUE CROSS ASSOCIATION
1968-01-16

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