Pacel™ 401762

GUDID 05414734001045

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Temporary cardiac pacing balloon catheter
Primary Device ID05414734001045
NIH Device Record Key840284e4-a19a-4890-b2db-c0a14255dbb2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePacel™
Version Model Number401762
Catalog Number401762
Company DUNS040960379
Company NameST. JUDE MEDICAL CARDIOVASCULAR DIVISION
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 Latextrue
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
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 Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734001045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDFELECTRODE, PACEMAKER, TEMPORARY

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 Date2016-01-28

On-Brand Devices [Pacel™]

15414734027288401769
15414734026519401765
05414734022521401764
05414734021906401761
05414734007856401763
15414734001233401776
15414734001219401775
15414734001196401774
15414734001172401773
15414734001158401772
15414734001134401771
15414734001110401770
15414734001097401768
15414734001073401767
15414734001059401766
05414734001045401762

Trademark Results [Pacel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACEL
PACEL
73760069 1539220 Live/Registered
DAIG CORPORATION
1988-10-27
PACEL
PACEL
73222307 1139867 Dead/Cancelled
Daig Corporation
1979-07-05

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