PageWriter

Basic Information

• Brand Name: PageWriter
• Primary DI: 00884838091689
• Version / Model: TC50 Government Bundle With Trolley
• Catalog Number: 860429
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 7
• Public Version Date: 2022-07-01
• Public Version Status: Update
• Public Device Record Key: e19b42e9-41d1-4ff5-91c2-f58d5610905a

Device Description

Includes A02 Cardiograph+A0X A Format+D01 All Orders (incl Manual Orders)+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG Archive+D08 DICOM ECG result output+D12 Last ECG InterAct Query+D24 Wireless 802 11+D50 A.07.05 (CE7)+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W02 Bench Repair+M2481A+13943B 10 packs+860309 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket

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: MR Unsafe
• 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
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16231	Electrocardiograph, professional, multichannel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838091689	GS1

Customer Contacts

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