CPS™ DS2A000

GUDID 05414734508889

ST. JUDE MEDICAL, INC.

Catheter slitter

• Primary Device ID: 05414734508889
• NIH Device Record Key: b039918e-d0a1-4844-9a65-ef9453967b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS™
• Version Model Number: 4F SLITTER
• Catalog Number: DS2A000
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734508889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082932

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-30

On-Brand Devices [CPS™]

• 05414734508889: 4F SLITTER
• 05414734508858: Cardiac Positioning System(CPS™)
• 05414734504287: Cardiac Positioning System(CPS™)
• 05414734218320: UNIVERSAL
• 05414734207218: VALVE BYPASS TOOL PL
• 05414734207041: Valve Bypass Tool PL
• 05415067046178: Universal II Slitter