Sensor Enabled™ A-FASE-CBL4

GUDID 05415067024916

Ablation Connection Cable

ST. JUDE MEDICAL, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 05415067024916
• NIH Device Record Key: b47832eb-6376-48dd-9d78-cf59b2632707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensor Enabled™
• Version Model Number: Cable
• Catalog Number: A-FASE-CBL4
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Length: 2.5 Meter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067024916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110016

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2017-02-22

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