CPS Aim™ DS2N100-65

GUDID 05415067041524

Universal II Slittable Inner Catheter (Subselector)

ST. JUDE MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 05415067041524
• NIH Device Record Key: f49177cb-27d7-48b5-b1fc-953eb58116de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS Aim™
• Version Model Number: DS2N100-65
• Catalog Number: DS2N100-65
• 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: false
• 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

Device Dimensions

• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 65 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15°- 25° C (59°- 77°F)
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067041524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221750

FDA Product Code

• DQY: Catheter, percutaneous

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: 2022-10-28
• Device Publish Date: 2022-10-20

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• 05414734509541: MediGuide Enabled™
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