FDA.report

ROLLO 50X50X16I.HELLIGE EK31

Primary DI
08428763003151
Brand
ROLLO 50X50X16I.HELLIGE EK31
Company
AB MEDICA GROUP, S.A.
Model
1005046
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
08428763003151PrimaryGS10

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
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods

Method

Regulatory Flags

DUNS number
460037021
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08428763008309PAQ. 80x90x280/QT-HS75/ GE MAC40029080012025-07-28
08428763008330PAQ.90X70X400*31*OTE.P-80.29090002025-07-28
08428763008347PAQ.90X90X400*31*SCH.AT1.MN.29090012025-07-28
08428763008354PAQ.90X90X200*31*SCH.AT4.MN.29090022025-07-28
08428763008361PAQ.90X90X360*28*MICROSMART.29090032025-07-28
08428763008385PAQ.90X90X360.MICROSMART.(MX)29090052025-07-28
08428763008392PAQ.90X90X130/QT-HS/ZOLL29090062025-07-28
08428763008415PAQ.104X100X300*31*CRDT-31.MN29104002025-07-28
08428763008439PAQ.106X140X200*31*BURD7971MN29106012025-07-28
08428763008446PAQ.108X140X200.ELI-15029108002025-07-28
08428763008453PAQ.110X100X300*31*NK.BL.MN.29110002025-07-28
08428763008460PAQ.110X150X300*31*FQW110315029110012025-07-28
08428763008477PAQ.110X100X200*31*BIOSET370029110022025-07-28
08428763008484PAQ.110X140X150.FQW110-2-14029110032025-07-28
08428763008491PAQ.110X150X200.FQW110-3-15029110042025-07-28
08428763008507PAQ.110X140X150.FQW1102140.MM29110052025-07-28
08428763008514PAQ.110X140X100.FUKUDA FX720229110062025-07-28
08428763008521PAQ.110X150X300.MEDTRONIC979029110072025-07-28
08428763008538PAQ.110X100X150.BIOSET 370029110082025-07-28
08428763008545PAQ. 110x140x140/QT-HS/ FX720229110092025-07-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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