SJM™ 401758

GUDID 15414734022146

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Electrocardiographic lead/catheter adaptor

• Primary Device ID: 15414734022146
• NIH Device Record Key: 0bc4cde7-ce7a-4067-a3ed-a19df104e40a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• Version Model Number: 401758
• Catalog Number: 401758
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• 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
• 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

• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter
• Length: 2.4 Meter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place. Keep dry and keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734022149 [Primary]
GS1	15414734022146 [Package]; Contains: 05414734022149; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910645

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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: 2018-07-06
• Device Publish Date: 2015-08-06

On-Brand Devices [SJM™]

• 15414734054253: 401777
• 15414734053676: 401760
• 15414734053652: 401759
• 15414734022146: 401758
• 15414734020043: 401748
• 15414734009673: 401778