PageWriter

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Hsg

Identity

Trade Name: PageWriter FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: 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 FDA UDI
Model / Reference: TC50 Government Bundle With Trolley FDA UDI
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 FDA UDI

Identifiers

Catalog Number: 860429 FDA UDI
Primary DI / UDI-DI: 00884838091689 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiograph, professional, multichannel

PageWriter by Philips Medical Systems Hsg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Philips Medical Systems Hsg

Sources (1)

FDA UDI e19b42e9-41d1-4ff5-91c2-f58d5610905a 35 fields · synced Jun 8, 2026