FDA.reportPublic FDA data

Paper

Primary DI
20884838116423
Brand
Paper
Company
Philips Medical Systems Hsg
Model
THERMAL PAPER FOR PAGEWRITER, A4 SIZE
Catalog number
M2483A
Device description
Thermal Paper for PageWriter, A4 size z-fold. Red grid w/6.7cm header. For PageWriter 200/i, 100 & XL cardiographs
Published
2025-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DSFRecorder, Paper Chart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838116423PrimaryGS10
00884838127708Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483811642320884838116423
00884838127708008848381277088848381277080884838127708

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic recording paperA device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

DUNS number
790605856
Device count
8
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838013544ECG ElectrodesECG Trunk Cable AAMI/IEC9898031722212016-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08428763001751ROLLO 57X15X12E/GR60/MICROTR.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001768ROLLO 57X15X12E/GR60/SPIRO501AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001775ROLLO 57X25X12E.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001782ROLLO 57X15X12E.MATACHANAAB MEDICA GROUP, S.A.DSF2025-11-12
08428763001805ROLLO 57X40X12E.PRINTER.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001812ROLLO 58X8X12E/GR60.PRINTERAB MEDICA GROUP, S.A.DSF2025-11-12
08428763007593PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008712PAQ.112X150X300.HEARTSCREEN CLINICAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008729PAQ.112X100X160.BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008736PAQ.112X90X160.CADENCE M50-78019AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008743PAQ.112X90X300.CARDICO-601AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008750PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008767PAQ.114X100X150.FETATRACK310AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008774PAQ.114X70X250/QT-75HS/WELCH ALLYN CP-5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008798PAQ.120X100X150*31*CTG.FHR240AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008811PAQ.120X100X150*31*CTG.FHR200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008859PAQ.120X100X300.K360/AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008866PAQ.120X150X250.ERGOCID.ATAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008873PAQ.120X100X300.AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008880PAQ.120x150x300 SPACELABS 90469AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008897PAQ. 120x100x(2x150) AR1200-OEM ET MEDIAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008927PAQ.126X150X170*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008941PAQ.126X150X150*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008989PAQ.134X100X300*31*DELTA-3.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009009PAQ.135X140X150*31*SCH.AT5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763009030PAQ.143X150X300*31*SONICAIDAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009047PAQ.143X150X300*31*SONICAID-NAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009061PAQ.144X75X400*31*BOSCH-FK.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009078PAQ.144X150X400*31*CRDT-3.MN.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763009085PAQ.144X100X350*31*SCH.AT6.MNAB MEDICA GROUP, S.A.DSF2025-11-12