HeartStart MRx monitor/defib

Basic Information

• Brand Name: HeartStart MRx monitor/defib
• Primary DI: 00884838045910
• Version / Model: 860397
• Catalog Number: 860397
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: a99a0fb3-3ccc-4670-8b54-a9c1a8105e78
• Distribution End Date: 2022-12-31

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: 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
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
48048	Rechargeable professional automated external defibrillator	A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838045910	GS1

Customer Contacts

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