FDA.reportPublic FDA data

PageWriter

Primary DI
00884838094819
Brand
PageWriter
Company
Philips Medical Systems Hsg
Model
PageWriter TC35 Cardiograph
Catalog number
860437
Device description
PageWriter TC35
Published
2023-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221141000PageWriter TC35 CardiographMedizin Systeme Boblingen GmbH2022-12-02DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838094819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838094819008848380948198848380948190884838094819

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57.2 KiloPascal101.4 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790605856
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838071074Smart CapnoLine / MicrostreamSmart CapnoLine H 02 Pediatric9898031779712017-08-23
20884838071081Smart CapnoLine / MicrostreamSmart CapnoLine H O2 Pediatric Long9898031779812017-10-13
20884838071111FilterLine / MicrostreamNasal FilterLine Infant/Neonatal9898031780212017-08-23
20884838071180VitaLine / MicrostreamTrade Compliant:VitaLineH Set, Adult/Ped9898031829412017-09-26
20884838071265Smart CapnoLine / MicrostreamSmart Capnoline Guardian O2 Long9898031830012017-03-29
20884838071494NIV Line/MicrostreamNIV Line / Pediatric9898031316512017-07-10
20884838071517CapnoLine/MicrostreamCapnoLine H / Infant/Neonatal9898031316812017-08-23
00884838089655Temperature ProbesE/R Temp Probe 12 FR Reuse Autoclavable9898032035612023-09-18
00884838089679Temperature ProbesSkin Temp Probe Reusable Autoclavable9898032035812023-09-18
20884838091836Microstream Advance Adult-Pediatric Intubated CO2 Filter LineAdt/Pedi Intub CO2 Line LTerm9898032045212021-07-23
00884838000476DigiTrak XTDigiTrak XT Holter Recorder8603222016-11-21
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11

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00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
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06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
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06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
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00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
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