AVEIR™ LSRMC01

GUDID 05415067046468

Patient Transmitter Wired Electrodes

ST. JUDE MEDICAL, INC.

Transtelephonic implantable pacemaker analysis system

• Primary Device ID: 05415067046468
• NIH Device Record Key: 793ce3f8-6066-4a7b-9141-22a88ad01eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVEIR™
• Version Model Number: LSRMC01
• Catalog Number: LSRMC01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067046468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150035

FDA Product Code

• PNJ: Leadless pacemaker

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

On-Brand Devices [AVEIR™]

• 05415067034847: Hydrophilic-Coated Introducer Sheath
• 05415067034823: Hydrophilic-Coated Introducer Sheath
• 05415067036384: Delivery Catheter
• 05415067034496: Retrieval Catheter
• 05415067034472: Leadless Pacemaker
• 05415067031914: Programmer Communication Module
• 05415067038487: Delivery Catheter
• 05415067040725: Leadless Pacemaker
• 05415067040701: Leadless Pacemaker
• 05415067046475: Patient Transmitter
• 05415067046468: Patient Transmitter Wired Electrodes
• 05415067049971: Patient Transmitter Software