FDA.report

Kendall

Primary DI
10884527009558
Brand
Kendall
Company
Cardinal Health, Inc.
Model
10643709
Catalog number
10643709
Device description
Medical Recording Chart Paper
Published
2018-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DSFRECORDER, PAPER CHART

Product Code Classifications

CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884527009558PrimaryGS10
20884527009555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452700955810884527009558
2088452700955520884527009555

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Regulatory Flags

DUNS number
080935429
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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08428763008309PAQ. 80x90x280/QT-HS75/ GE MAC400AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008330PAQ.90X70X400*31*OTE.P-80.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008347PAQ.90X90X400*31*SCH.AT1.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008354PAQ.90X90X200*31*SCH.AT4.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008361PAQ.90X90X360*28*MICROSMART.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008385PAQ.90X90X360.MICROSMART.(MX)AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008392PAQ.90X90X130/QT-HS/ZOLLAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008415PAQ.104X100X300*31*CRDT-31.MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008439PAQ.106X140X200*31*BURD7971MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008446PAQ.108X140X200.ELI-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008453PAQ.110X100X300*31*NK.BL.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008460PAQ.110X150X300*31*FQW1103150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008477PAQ.110X100X200*31*BIOSET3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008484PAQ.110X140X150.FQW110-2-140AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008491PAQ.110X150X200.FQW110-3-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008507PAQ.110X140X150.FQW1102140.MMAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008514PAQ.110X140X100.FUKUDA FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008521PAQ.110X150X300.MEDTRONIC9790AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008538PAQ.110X100X150.BIOSET 3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008545PAQ. 110x140x140/QT-HS/ FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008552PAQ.110X140X150.GE.MAC800AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008569PAQ.110X140X140/QT-HS/OEM BEXEN XEG114AAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008583PAQ.111X100X200.ORIONAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008590PAQ.112X100X300*31*DELTA3.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008613PAQ.112X90X300.SUZ-KENZAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008637PAQ.112X100X300/QI-HS/GOLDWAYAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008644PAQ.112X90X160.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008651PAQ.112X100X100.SRF618BAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008668PAQ.112X100X300.ELAN1100AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008675PAQ.112X90X150.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28