CPS DIRECT™ DS2M022

GUDID 05415067003775

MediGuide Enabled™ Slittable Outer Guide Catheter 115

ST. JUDE MEDICAL, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID05415067003775
NIH Device Record Keyf3477901-d876-4998-941a-74aedc3ba45b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPS DIRECT™
Version Model NumberMEDIGUIDE ENABLED™
Catalog NumberDS2M022
Company DUNS790268031
Company NameST. JUDE MEDICAL, 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

Device Dimensions

Length18.5 Inch
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch
Length47 Centimeter
Length18.5 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not crush.
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067003775 [Primary]

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2016-04-21

On-Brand Devices [CPS DIRECT™]

05415067004291Universal
05415067004284Universal
05415067004260Universal
05415067004253Universal
05415067004246Universal
05415067004239Universal
05415067004222Universal
05415067004215Universal
05415067004208Universal
05415067004192Universal
05415067004185Universal
05415067004178Universal
05415067003799MediGuide Enabled™ Slittable Outer Guide Catheter W
05415067003782MediGuide Enabled™ Slittable Outer Guide Catheter 135
05415067003775MediGuide Enabled™ Slittable Outer Guide Catheter 115
05414734509497MediGuide Enabled™
05414734509480MediGuide Enabled™
05414734509473MediGuide Enabled™
05414734509466MediGuide Enabled™
05414734218337DS2A004
05414734218313Slittable Outer Guide Catheter
05414734218290Slittable Outer Guide Catheter
05414734218283SLII
05414734218276Slittable Outer Guide Catheter
05414734218269SLII
05414734218252Slittable Outer Guide Catheter
05414734218245SLII
05414734218238Slittable Outer Guide Catheter
05414734218221SLII
05414734218214SLII
05414734218207SLII
05414734218191Slittable Outer Guide Catheter
05414734218009Slittable Outer Guide Catheter
05414734206938PL
05414734206921PL
05414734206914PL
05414734206907PL
05414734206891PL
05414734206884PL
05414734206877PL
05414734206860PL
05414734206853PL
05414734206846PL
05414734206839PL
05414734206822PL
05414734206815PL
05414734206808PL
05414734206792PL
05414734206785PL
05414734207201Peelable Outer Guide Catheter

Trademark Results [CPS DIRECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CPS DIRECT
CPS DIRECT
78739232 3231537 Live/Registered
Pacesetter, Inc.
2005-10-24

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