Merlin™ EX3180

GUDID 05414734503136

ST. JUDE MEDICAL, INC.

External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser External pacemaker analyser

• Primary Device ID: 05414734503136
• NIH Device Record Key: 155aefa7-7550-4e1c-b416-5edb5f418417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merlin™
• Version Model Number: PSA "M" Adapter
• Catalog Number: EX3180
• Company DUNS: 790268031
• 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: 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch
• Length: 10 Inch

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734503136 [Primary]

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-04
• Device Publish Date: 2014-09-30

On-Brand Devices [Merlin™]

• 05414734509725: Software Upgrade Kit
• 05414734503143: Antenna Adapter
• 05414734503136: PSA "M" Adapter
• 05414734503129: PSA Cable Adapter
• 05414734502078: Merlin™ Antenna
• 05414734500661: Patient Care System
• 05415067037121: Software for Merlin 2.0
• 05415067031174: Patient Care System (PCS)