FDA.reportPublic FDA data

EKG Patch (Pediatric 1)

Primary DI
00860007764462
Brand
EKG Patch (Pediatric 1)
Company
Mg Medical Products LLC
Model
1
Catalog number
PA010PO10213C
Device description
Electrocardiograph Electrode Patch (Pediatric 1)
Published
2025-02-25
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
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007764462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007764462008600077644628600077644620860007764462

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory recorder conductive patchAn adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094834451
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007764431EKG Patch (Pediatric 4)1PA010PO40213C2025-02-25
00860007764448EKG Patch (Pediatric 3)1PA010PO30213C2025-02-25
00860007764455EKG Patch (Pediatric 2)1PA010PO20213C2025-02-25
00860007764424EKG Patch Solution1EPSK001CLPA020MG2025-01-09
00198715993158EKG Patch Solution1EPSK001CLPA020MG2024-12-19
00860007764400EKG Patch (Medium)Adult 2.0 MediumPA020AOM0213C2021-10-25
00860007764417EKG Patch (Large)Adult 2.0 LargePA020AOL0213C2021-10-25

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Primary DI, Brand, Company table
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08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
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