FDA.reportPublic FDA data

myCordella Patient Kit

Primary DI
00850008997068
Brand
myCordella Patient Kit
Company
Endotronix, Inc.
Model
100171-00
Device description
myCordella Patient Kit consists of the myCordella Tablet and PeripheralsmyCordella TabletAn intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements.• Collects & securely transmits daily health information to doctors• Provides secure communication between patient and doctor• Provides access to patient education materials• Facilitates review of past measurements• Facilitates review of patient goalsmyCordella PeripheralsMedical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.
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
00850008997068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008997068008500089970688500089970680850008997068

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
806850835
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008997037myCordella Patient App100256-022024-08-13
00850008997044myCordella Patient Management Portal100258-002024-08-13
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
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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
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