ViewFlex™ 100043720

GUDID 05415067002907

Catheter Interface Module

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 05415067002907
• NIH Device Record Key: e65c96f0-deaf-4715-9e83-3e58d2ca3cbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewFlex™
• Version Model Number: 100043720
• Catalog Number: 100043720
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Do not use if package is damaged.
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002907 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-09

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