CPS™ DS2A006

GUDID 05415067046178

Universal II Slitter

ST. JUDE MEDICAL, INC.

Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter 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