CPS™ DS2A003

GUDID 05414734218320

ST. JUDE MEDICAL, INC.

Cardiovascular device introducer, steerable

• Primary Device ID: 05414734218320
• NIH Device Record Key: 4f452ec1-a8a1-4e14-94be-bb65f9f5e1d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS™
• Version Model Number: UNIVERSAL
• Catalog Number: DS2A003
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734218320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092075

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: 2015-04-01

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