CORE12

GUDID 00853512007001

Multi Function Device

APPLIED CARDIAC SYSTEMS, INC.

Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 00853512007001
• NIH Device Record Key: 47b9d0b7-7f82-4fda-b2a8-c1ea0c5ae5e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE12
• Version Model Number: C18006
• Company DUNS: 063186910
• Company Name: APPLIED CARDIAC SYSTEMS, 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: 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: 9499006144
• Email: mwright@appliedcardiacsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512007001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103706

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-03-27