AccessGUDID - DEVICE: myCordella Patient Kit (00850008997068)

GUDID

Device Identifier (DI) Information

Brand Name: myCordella Patient Kit
Version or Model: 100171-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Endotronix, Inc.

Primary DI Number: 00850008997068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806850835 *Terms of Use

Device Description: myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An 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 goals myCordella Peripherals Medical 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66386	Bedside monitor remote-viewing software, physiological parameter	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEZ	Cardiovascular Procedure Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 196d8dbd-8b06-4a1b-afe4-dec3b861e357
Public Version Date: August 21, 2024
Public Version Number: 1
DI Record Publish Date: August 13, 2024