CPS™ DS2A006

GUDID 05415067046178

Universal II Slitter

ST. JUDE MEDICAL, INC.

Intravascular catheter slitter

• Primary Device ID: 05415067046178
• NIH Device Record Key: 122d5235-319a-4d60-97e6-d729d297f65f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS™
• Version Model Number: DS2A006
• Catalog Number: DS2A006
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted: -20°-50°C, -4°-122°F
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 0
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067046178 [Primary]

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-10
• Device Publish Date: 2022-11-02

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