FDA.reportPublic FDA data

EKG Patch Solution

Primary DI
00198715993158
Brand
EKG Patch Solution
Company
Mg Medical Products LLC
Model
1
Catalog number
EPSK001CLPA020MG
Device description
Portable, 12-lead ECG testing kit.
Published
2024-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198715993158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715993158001987159931581987159931580198715993158

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094834451
Device count
1
Premarket exempt
true
Kit
true
Manufacturing 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
00860007764400EKG Patch (Medium)Adult 2.0 MediumPA020AOM0213C2021-10-25
00860007764417EKG Patch (Large)Adult 2.0 LargePA020AOL0213C2021-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450161746Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450436745Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
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