FDA.reportPublic FDA data

EKG Patch (Large)

Primary DI
00860007764417
Brand
EKG Patch (Large)
Company
Mg Medical Products LLC
Model
Adult 2.0 Large
Catalog number
PA020AOL0213C
Device description
Electrocardiograph Electrode Patch (Adult Large)
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00860007764417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007764417008600077644178600077644170860007764417

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

Contacts#

Phone, Email table
PhoneEmail
5132310250sbittinger@mgmedpro.com

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
00860007764462EKG Patch (Pediatric 1)1PA010PO10213C2025-02-25
00860007764424EKG Patch Solution1EPSK001CLPA020MG2025-01-09
00198715993158EKG Patch Solution1EPSK001CLPA020MG2024-12-19
00860007764400EKG Patch (Medium)Adult 2.0 MediumPA020AOM0213C2021-10-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20