FDA.reportPublic FDA data

Paper

Primary DI
00884838001121
Brand
Paper
Company
Philips Medical Systems Hsg
Model
1-CHANNEL CHEMICAL THERMAL PAPER, GRAY
Catalog number
40457C
Device description
1-Channel Chemical Thermal Paper, Gray
Published
2019-07-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00884838001121PrimaryGS10
10884838001128Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838001121008848380011218848380011210884838001121
1088483800112810884838001128

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 Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790605856
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253055931KendallCardinal Health 200, LLCDSF2026-06-19
10192253055955KendallCardinal Health 200, LLCDSF2026-06-19
20192253055884KendallCardinal Health 200, LLCDSF2026-06-19
00884838120358Thermal Printer Kit, USBPhilips Medizin Systeme Böblingen GmbHDSF2026-06-04
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