ViewFlex™ H701374

GUDID 05415067013743

Catheter Interface Module

ST. JUDE MEDICAL, INC.

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 05415067013743
• NIH Device Record Key: 32b65142-a96c-432d-bea4-e83c06bbd095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewFlex™
• Version Model Number: H701374
• Catalog Number: H701374
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if packaging is damaged.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067013743 [Primary]

FDA Product Code

• DRJ: SYSTEM, SIGNAL ISOLATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-16
• Device Publish Date: 2016-05-06

On-Brand Devices [ViewFlex™]

• 05415067013750: Catheter Interface Module
• 05415067013743: Catheter Interface Module
• 05415067002969: Catheter Interface Module
• 05415067002907: Catheter Interface Module
• 05415067002655: Catheter Interface Module
• 05415067049285: Catheter Interface Module
• 05415067049278: Catheter Interface Module