CPS™ DS2A000

GUDID 05414734508889

ST. JUDE MEDICAL, INC.

Catheter slitter Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter
Primary Device ID05414734508889
NIH Device Record Keyb039918e-d0a1-4844-9a65-ef9453967b57
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPS™
Version Model Number4F SLITTER
Catalog NumberDS2A000
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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

Device Dimensions

Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French

Operating and Storage Conditions

Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark dry place. Away from sunlight.
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark dry place. Away from sunlight.
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark dry place. Away from sunlight.
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark dry place. Away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734508889 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-03-30

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05414734207041Valve Bypass Tool PL
05415067046178Universal II Slitter

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