NA

Basic Information

• Brand Name: NA
• Primary DI: 00884838022164
• Version / Model: 862120
• Catalog Number: 862120
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 4
• Public Version Date: 2021-11-24
• Public Version Status: Update
• Public Device Record Key: 27f23ccd-d10a-4525-b344-4582c4150226

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
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34937	Paper chart recorder	A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838022164	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021422	000