SJM CONFIRM™ DM2100A

GUDID 05414734502696

External Patient Activator

ST. JUDE MEDICAL, INC.

Implantable cardiac monitor programmer/transmitter/alarm

• Primary Device ID: 05414734502696
• NIH Device Record Key: 2be00df7-1e5b-4e52-81db-2e7e213c8493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM CONFIRM™
• Version Model Number: DM2100A
• Catalog Number: DM2100A
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734502696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101968

FDA Product Code

• MXC: RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

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: 2020-01-09
• Device Publish Date: 2017-04-10

On-Brand Devices [SJM CONFIRM™]

• 05414734502696: External Patient Activator
• 05414734502597: Implantable Cardiac Monitor
• 05414734502573: Implantable Cardiac Monitor with AF detection