AccessGUDID - DEVICE: Emay (04897087206120)

GUDID

Device Identifier (DI) Information

Brand Name: Emay
Version or Model: EMG-6L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EMAY (HK) LIMITED

Primary DI Number: 04897087206120
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 664020405 *Terms of Use

Device Description: It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.

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):	Yes
Kit:	No
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?
38729	Telemetric electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPS	Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152863	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51c70413-e90c-4dd6-bd36-4432246dfa1a
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023