FDA.reportPublic FDA data

ROLLO 57X25X12E.

Primary DI
08428763001775
Brand
ROLLO 57X25X12E.
Company
AB MEDICA GROUP, S.A.
Model
0505702
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
08428763001775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08428763001775084287630017758428763001775

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
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

Regulatory Flags#

DUNS number
460037021
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08428763001751ROLLO 57X15X12E/GR60/MICROTR.05057002025-11-12
08428763001768ROLLO 57X15X12E/GR60/SPIRO50105057012025-11-12
08428763001782ROLLO 57X15X12E.MATACHANA05057032025-11-12
08428763001805ROLLO 57X40X12E.PRINTER.05057052025-11-12
08428763001812ROLLO 58X8X12E/GR60.PRINTER05058002025-11-12
08428763007593PAQ.112X100X100BIOCARE24398012025-11-12
08428763008712PAQ.112X150X300.HEARTSCREEN CLINIC29112122025-11-12
08428763008729PAQ.112X100X160.BIOCARE29112132025-11-12
08428763008736PAQ.112X90X160.CADENCE M50-7801929112142025-11-12
08428763008743PAQ.112X90X300.CARDICO-60129112152025-11-12
08428763008750PAQ.112X100X100BIOCARE29112162025-11-12
08428763008767PAQ.114X100X150.FETATRACK31029114002025-11-12
08428763008774PAQ.114X70X250/QT-75HS/WELCH ALLYN CP-529114012025-11-12
08428763008798PAQ.120X100X150*31*CTG.FHR24029120002025-11-12
08428763008811PAQ.120X100X150*31*CTG.FHR20029120022025-11-12
08428763008859PAQ.120X100X300.K360/AR120029120062025-11-12
08428763008866PAQ.120X150X250.ERGOCID.AT29120072025-11-12
08428763008873PAQ.120X100X300.AR120029120082025-11-12
08428763008880PAQ.120x150x300 SPACELABS 9046929120092025-11-12
08428763008897PAQ. 120x100x(2x150) AR1200-OEM ET MEDI29120102025-11-12

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
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
08428763009092PAQ.144X150X400*31*FUKUDA.MNDAB MEDICA GROUP, S.A.DSF2025-11-12