Agilis HisPro™ DS3A001

GUDID 05415067035028

Slitter

ST. JUDE MEDICAL, INC.

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• Primary Device ID: 05415067035028
• NIH Device Record Key: 95d654b5-f457-4224-8fc1-a837ab272493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agilis HisPro™
• Version Model Number: DS3A001
• Catalog Number: DS3A001
• 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
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067035028 [Primary]

FDA Product Code

• DQY: Catheter, percutaneous
• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

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

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

[05415067035028]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-01
• Device Publish Date: 2021-06-23

On-Brand Devices [Agilis HisPro™]

• 05415067032287: Steerable Catheter with Electrodes
• 05415067035028: Slitter