CPS AIM™ DS2N101-59

GUDID 05415067041777

Universal II Slittable Inner Catheter (Subselector)

ST. JUDE MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 05415067041777
• NIH Device Record Key: b974121d-076c-4ba8-a123-55fabe3b94eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS AIM™
• Version Model Number: DS2N101-59
• Catalog Number: DS2N101-59
• 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: 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
• 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: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter
• Catheter Gauge: 8 French
• Outer Diameter: 2.46 Millimeter
• Length: 59 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 20 Degrees Celsius
• 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
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 68 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067041777 [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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• 05415067005731: Universal
• 05415067005724: Universal
• 05415067005717: Universal
• 05414734509541: MediGuide Enabled™
• 05414734509534: MediGuide Enabled™
• 05414734509527: MediGuide Enabled™
• 05414734509510: MediGuide Enabled™
• 05414734509503: MediGuide Enabled™
• 05414734218184: SL
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• 05414734218085: SL
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• 05414734218061: SL
• 05414734218054: SL
• 05414734218047: SL
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• 05415067041760: Universal II Slittable Inner Catheter (Subselector)
• 05415067041753: Universal II Slittable Inner Catheter (Subselector)
• 05415067041746: Universal II Slittable Inner Catheter (Cannulator)
• 05415067041739: Universal II Slittable Inner Catheter (Subselector)
• 05415067041586: Universal II Slittable Inner Catheter (Cannulator)
• 05415067041524: Universal II Slittable Inner Catheter (Subselector)
• 05415067041517: Universal II Slittable Inner Catheter (Subselector)