Ascom

Basic Information

• Brand Name: Ascom
• Primary DI: 17350088670016
• Version / Model: Cardiomax
• Catalog Number: SW000466
• Company Name: Ascom (Sweden) AB
• Labeler DUNS: 356107490
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2f3d1a1d-dda1-451a-b91c-e499db3d4049

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MSX	System,Network And Communication,Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40573	Alarm application software	An individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines can be upgraded to correct programming errors or to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software may also be produced for installation in an off-the-shelf desktop or laptop computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17350088670016	GS1

Premarket Submissions

Submission Number	Supplement Number
K103634	000