FDA.reportPublic FDA data

PageWriter

Primary DI
00884838028784
Brand
PageWriter
Company
Philips Medical Systems Hsg
Model
PageWriter TC20 Cardiograph
Catalog number
860332
Device description
PageWriter TC20 Cardiograph
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWJELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113144000PAGEWRITER TC 20, 30, 50, 70Philips Medical Systems2012-04-03DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838028784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838028784008848380287848848380287840884838028784

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure572 millibar1014 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
790605856
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838015245HeartStartExternal Paddles Water ResistantM3543A2014-09-24
00884838090088MX40 Masimo Leadsets and AdaptersMX40 Adapter 5-Lead + Masimo SpO29898032023812022-05-23
00884838090095MX40 Masimo Leadsets and AdaptersMX40 Adapter Masimo SpO2-only9898032023912022-05-23
00884838090101MX40 Masimo Leadsets and AdaptersECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112020-04-21
00884838090118MX40 Masimo Leadsets and AdaptersECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212020-04-21
00884838091276MX40 Masimo Leadsets and AdaptersMX40 Adapter 6-Lead + Masimo SpO29898032042912020-04-21
00884838013360ECG ElectrodesCBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE9898031718112017-07-13
00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
00884838013391ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE9898031718412016-09-27
00884838013407ECG ElectrodesCBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE9898031718512016-09-27
00884838013414ECG ElectrodesCBL ECG 6 LEAD GRABBER, AAMI, TELE9898031718612017-07-27
20884838013517ECG ElectrodesCBL ECG 5 LEAD GRABBER IEC, SPU, TELE9898031721312020-03-25
20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13
00884838013476ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC, TELE9898031719612016-11-01
00884838013483ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE9898031719712016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04