FDA.report

CARDINAL HEALTH

Primary DI
50192253055656
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
10669183
Catalog number
10669183
Device description
Medical Recording Chart Paper
Published
2023-01-04
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
50192253055656PackageGS16In Commercial Distribution
20192253055655PrimaryGS10
10192253055658Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225305565650192253055656
2019225305565520192253055655
1019225305565810192253055658

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
8
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

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10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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08428763008415PAQ.104X100X300*31*CRDT-31.MNAB MEDICA GROUP, S.A.DSF2025-07-28
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