CardioMessenger

Basic Information

• Brand Name: CardioMessenger
• Primary DI: 04035479139360
• Version / Model: Smart 3G
• Catalog Number: 401831
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8d66e0ce-7f22-4c61-80bf-a88ac22002ec

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OSR	Pacemaker/icd/crt non-implanted components	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60106	Patient monitoring modem	A portable adaptor/modem intended to connect an electronic device that monitors a patient’s physiologic parameters (e.g., an active-implantable-device communicator that receives signals from an implanted pulse generator such as a cardiac pacemaker) to an analogue telephone line, to send digital information from the monitoring device to a healthcare facility transtelephonically. It typically consists of a small housing with a telephone line socket and a patient monitor connection lead. This device may be used in cases when a patient monitor capable of sending patient data via a mobile telephone (cellular) network has no signal.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479139360	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]