AccessGUDID - DEVICE: Samsung ECG Monitor Application (08806090792021)

GUDID

Device Identifier (DI) Information

Brand Name: Samsung ECG Monitor Application
Version or Model: 1.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Samsung Electronics Co., Ltd.

Primary DI Number: 08806090792021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687967554 *Terms of Use

Device Description: No description.

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?
35195	Electrocardiographic monitor	A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QDA	Electrocardiograph Software For Over-The-Counter Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201168	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: 6b684bc7-f193-4557-9514-664cdfba8c53
Public Version Date: June 03, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020