FDA.reportPublic FDA data

myCordella Patient App

Primary DI
00850008997037
Brand
myCordella Patient App
Company
Endotronix, Inc.
Model
100256-02
Device description
myCordella Patient App is a component of the myCordella Patient Kit.myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements.• Collects & securely transmits daily health information to clinicians• Facilitates review of past measurements• Allows secure communication between patient and clinician
Published
2024-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850008997037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008997037008500089970378500089970370850008997037

GMDN Terms#

Term, Definition table
TermDefinition
Bedside monitor remote-viewing software, physiological parameterAn application software program intended to be installed on a smart device (e.g., smartphone, tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from bedside monitors via data transmission through a centralized patient monitor. It is designed for viewing data only as a telemedicine application intended to support, and not replace, standard patient monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888 512 5595support@endotronix.com

Regulatory Flags#

DUNS number
806850835
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008997044myCordella Patient Management Portal100258-002024-08-13
00850008997068myCordella Patient Kit100171-002024-08-13
00850008997143myCordella Handheld Patient Reader Alloy100102-02 2025-10-13
00850008997006Cordella Sensor Delivery Kit100303-052024-08-14
00850008997013myCordella Handheld Patient Reader100102-012024-08-13
00850008997020Cordella Calibration Equipment100622-002024-08-13
00850008997051Cordella Data Analysis Platform100543-002024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450428313Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-28
00884450487532Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-28
10809160522042HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160522066HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160522097HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160521984HalyardAVID MEDICAL, INC.OEZ2026-05-27
H65857031555Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031565Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031315Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-10
H65857030865Henry ScheinHENRY SCHEIN, INC.OEZ2022-05-25
H65857029425Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
H65857029535Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
10193489040166NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040180NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
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