FDA.report

CARDINAL HEALTH

Primary DI
50192253056097
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
9019
Catalog number
9019
Device description
Medical Recording Chart Paper
Published
2023-03-27
Public version status
New
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
50192253056097PackageGS120In Commercial Distribution
10192253056099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225305609750192253056097
1019225305609910192253056099

GMDN Terms

TermDefinition
Paper chart recorderA mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
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10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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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
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08428763008484PAQ.110X140X150.FQW110-2-140AB MEDICA GROUP, S.A.DSF2025-07-28
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08428763008507PAQ.110X140X150.FQW1102140.MMAB MEDICA GROUP, S.A.DSF2025-07-28
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